Find The Best Regulatory Affairs Director Jobs For You

Where do you want to work?

0 selections

Top Regulatory Affairs Director Skills

Below we've compiled a list of the most important skills for a regulatory affairs director. We ranked the top skills based on the percentage of regulatory affairs director resumes they appeared on. For example, 13.1% of regulatory affairs director resumes contained regulatory agencies as a skill. Let's find out what skills a regulatory affairs director actually needs in order to be successful in the workplace.

Want to find jobs that match your skillset?
Get recommendations that fit your preferences and skillset. We’ll recommend jobs that fit your skills and key steps to help you stand out to employers. Answer a few questions and get started.
The six most common skills found on Regulatory Affairs Director resumes in 2020. Read below to see the full list.

1. Regulatory Agencies

high Demand

Here's how Regulatory Agencies is used in Regulatory Affairs Director jobs:
  • Prepared and filed annual and quarterly financial statements with regulatory agencies in three states and the Federal Energy Regulatory Commission.
  • Maintained excellent working relationships with regulatory agencies, internal project team members, collaborations/partners.
  • Direct interface with international regulatory agencies in order to expedite approval of pending registration.
  • Worked closely with local and state law enforcement and/or regulatory agencies.
  • Developed Target Product Profile to better communications with regulatory agencies.
  • Coordinate activities for paper-based and electronic submissions with regulatory agencies.
  • Prepare information or responses as requested by regulatory agencies.
  • Interact with regulatory agencies to secure filing approvals.
  • Represent the company in meetings with regulatory agencies, trade associations (PHSP Coalition, AHIP, and HPA).
  • Maintain an active line of communication with FDA or other regulatory agencies directed at driving corporate goals and company priorities.
  • Lead preparations for, and participate in, meetings with regulatory agencies to ensure successful regulatory outcomes.
  • Develop strategic regulatory approaches to various regulatory agencies (FDA, NB, HC).
  • Established and maintained relationships with regulatory agencies, suppliers, academic partners, and customers.
  • Served as primary liaison with the FDA investigators, auditors, and other regulatory agencies.
  • Participated in Private Label partner audits and inspections by FDA and other regulatory agencies.
  • Interact with U.S. and international regulatory agencies, along with AdvaMed.
  • Maintained continuing liaison with the personnel of these regulatory agencies.
  • Prepare of submissions, and correspondence to regulatory agencies.
  • Championed regional drug regulatory agencies harmonization between WADRAN and EADRAN.

Show More

2. Regulatory Affairs

high Demand

Here's how Regulatory Affairs is used in Regulatory Affairs Director jobs:
  • Selected by senior leadership to participate in the Abbott Regulatory Council key business initiative program to improve Regulatory Affairs across Abbott.
  • Represented Regulatory Affairs on promotional materials review committees, medical information working groups, and scientific exchange review committees.
  • Served as primary regulatory affairs leader for registration and compliance of pharmaceuticals and medical devices related to pain relief.
  • Manage and oversee all projects assigned to the Regulatory Affairs Department to ensure timely and effective implementation.
  • Orchestrated the transition of regulatory responsibilities from external consultants to the newly created Regulatory Affairs Department.
  • Defined tracking mechanisms and tools for regulatory affairs projects, resulting in greater efficiency and productivity.
  • Direct domestic and international regulatory affairs, clinical research and quality assurance.
  • Make recommendation on potential improvements to the Regulatory Affairs department.
  • Defined and implemented a comprehensive Corporate & Regulatory Affairs Strategy.
  • Developed the Director of Government and Regulatory Affairs position.
  • Managed corporate regulatory affairs and compliance personnel.
  • Assumed dual executive duties with the assignment of the Regulatory Affairs department in additional to the management of the Materiel department.
  • Support administration and maintenance of the document repositories and document control areas of Regulatory Affairs (both paper and electronic).
  • Directed the technical, code, and regulatory affairs activities for over thirteen producer and thirty-eight associate members of VSI.
  • Project teams typically include sales, marketing, engineering, manufacturing, regulatory affairs, technical service and research.
  • Lead the Corporate Regulatory Affairs Division of the Legal Department in a fast-paced, dynamic, results-driven environment.
  • Strengthened and grew Regulatory Affairs team to manage unprecedented activity load in the history of the company.
  • Provided scientific and regulatory affairs expertise and leadership for Corporate HQ and the North American business unit.
  • Assure the proper management, retention, and version control of all applicable Regulatory Affairs documentation.
  • Maintain direct management responsibility for the Regulatory Affairs Department and its staff of 8 employees.

Show More

3. FDA

high Demand

Here's how FDA is used in Regulatory Affairs Director jobs:
  • Maintained regular contact and consulted as required with counsel knowledgeable in FDA regulatory matters.
  • Review incoming FDA correspondence and collaborated in the determination of required elements for response.
  • Co-authored all US and International regulatory FDA briefing and presentation packages.
  • Reviewed and edited clinical protocols and supporting documentation for FDA submissions.
  • Directed and provided strategic guidance for regulatory submissions and led FDA liaison activities(average 5-6 meetings/year).
  • Review all labeling and informational materials sent to FDA for completeness, truthfulness, and compliance with regulations.
  • Research FDA regulations, medical resources, websites and other sources on new products and projects as assigned.
  • Attended FDA meetings; Lead FDA liaison, experience with New Drug and Office of Generic Drugs.
  • Provide regulatory consultation to other departments, i.e., manufacturing, product compliance based on FDA regulations.
  • Assisted in obtaining U.S. FDA approval for API manufacturing facilities in Russia, Poland and South Africa.
  • Represented the company during one Federal FDA (QSR/GMP 21CFR 820) and one State FDA inspection.
  • Draft drug product labeling based on the reference listed drug (RLD) and FDA requirements.
  • Ensured the timely submission of well-organized and scientifically sound Regulatory packages to FDA and NIH OBA.
  • Obtained IDE approval from FDA for a clinical trial for a Whole Blood illumination dosing study.
  • Reviewed and approved changes to manufacturing processes to ensure compliance with FDA and GMP guidelines.
  • Supported four FDA audits as the Supplier Quality Assurance Management Representative with Zero 483's.
  • Represented the company during one Federal FDA (QSR/GMP 21 CFR 820) inspection.
  • Set up early retrospective clinical trials to satisfy new FDA requirements for implantable products.
  • Interacted successfully with federal agencies (FDA, OSHA) during on-site GMP inspections.
  • Submitted 2301/2253 pharmaceutical promotional content to the Food and Drug Administration (FDA).

Show More

4. Procedures

high Demand

Here's how Procedures is used in Regulatory Affairs Director jobs:
  • Monitored and coordinated contractors/vendors access to ensure compliance company vendor policies and procedures, including insurance requirements to protect the property/company.
  • Directed and led company-wide cross-functional process improvement efforts, resulting in establishment of new procedures for communications with health authorities.
  • Develop and implement standard operating procedures and guidelines for clinical trials and related activities in the division of cardiology.
  • Support the preparation of scientifically sound Regulatory submissions in line with requirements and company policies and procedures.
  • Developed standard operating procedures including intervention plans, SQF/BRC procedures, and testing procedures.
  • Developed regulatory policies and procedures, including a regulatory compliance function.
  • Coordinated legal and contractual procedures with foreign office Managing Directors.
  • Maintain a broad knowledge of principles, practices, procedures, laws and regulations to proactively diagnose problems and identify solutions.
  • Developed global policies and procedures to define best practices and tools for use in Scientific, Strategic and Tactical Operations.
  • Developed Compliance program policies and procedures as a member of the Office of Program Integrity.
  • Maintain and revise all departmental policies and procedures.
  • Reviewed changes in manufacturing facilities, manufacturing procedures, and analytical methods.
  • Obtain or provider interpretative guidance upon request Review and approve external departmental policies, procedures, and manuals, as appropriate.
  • Developed Standard Operating Procedures (SOPs) and Working Practices governing review and approval of external communications.
  • Maintain working knowledge of laboratory industry compliance, keyindustry topics, procedures, issues and concerns.
  • Develop Corporate and Standard Operating Procedures, compliance programs, FMEA, preproduction design assurance programs.
  • Create and deliveron-boarding procedures for all new faculty members.

Show More

5. Regulatory Strategy

high Demand

Here's how Regulatory Strategy is used in Regulatory Affairs Director jobs:
  • Developed Regulatory strategy and provided guidance for expanding existing and new product(s) into international markets.
  • Managed regulatory strategy, regulatory risk and attained desired regulatory results in Mid-Atlantic region of US.
  • Assisted employees in regional regulatory strategy development and execution.
  • Led regulatory strategy for manufacturing transfers.
  • Provided Regulatory strategy and support for gene therapy product development in the US, Canada, Europe, and Argentina.
  • Developed a 510k Regulatory Strategy that improved the accuracy/response time by 15% and 60% respectively.
  • Initiated and led Global Chemical Regulatory Strategy team to quickly react to regional needs.

Show More

Job type you want
Full Time
Part Time
Internship
Temporary

6. Global Regulatory

high Demand

Here's how Global Regulatory is used in Regulatory Affairs Director jobs:
  • Drug facility registrations and listings for global regulatory health agencies and state licensing, including animal feed transportation taxes.
  • Identify global regulatory trends & their implications, taking into consideration the impact on business decisions.
  • Analyzed U.S. and global regulatory trends and initiated opportunistic and defensive projects to support business goals.
  • Maintained a history of successful interactions with global regulatory authorities.
  • Build teams, introduce policies, identify global regulatory requirements and create strategies that align with business priorities and goals.
  • Review global Regulatory submissions to ensure they are complete, accurate and consistent with corporate objectives.
  • Involved with strategic global regulatory and clinical planning, and successful execution of such planning.
  • Major Accomplishments: Built global regulatory team/infrastructure to support diagnostic business PMA approval of a companion diagnostic assay.

Show More

7. Regulatory Submissions

high Demand

Here's how Regulatory Submissions is used in Regulatory Affairs Director jobs:
  • Review and determine the applicability of supporting documentation for inclusion in Regulatory submissions.
  • Oversee in-house and external document publishing activities for paper and electronic submissions.
  • Provided support to process solutions in submission capacity assessments for electronic submissions.
  • Project Manager for multiple regulatory submissions ongoing with collaborators.
  • Provide consultation for international regulatory submissions.
  • Direct the planning and preparation US and International Regulatory Submissions (EMA, MCC, WHO, and African Countries).
  • Prepare and compile all regulatory submissions for the Company's products.
  • Drafted, reviewed and negotiated regulatory submissions to ensure they met appropriatestandards and content requirements.

Show More

8. EU

high Demand

Here's how EU is used in Regulatory Affairs Director jobs:
  • Calculated: Nutritional Facts, LD50, %VOC, Vapor Pressure, %HC, & EU Sensitizer Declarations.
  • Manage corporate review and approval of CCDSs, US PIs, EU SmPCs and other regional prescribing information.
  • Managed regulatory compliance of EU technical documentation and interfaced with external auditors as a technical documentation subject matter expert.
  • Provide regulatory intelligence involving review and interpretation of US and EU regulations and guidelines for internal project teams.
  • Prepared new technical documentation for EU, Canada and Australian product registration/submission.
  • Coordinated large-scale revision of EU Regulatory submission documentation system.

Show More

9. IND

high Demand

Here's how IND is used in Regulatory Affairs Director jobs:
  • Edited collaborators regulatory filings including Appendix M and initial IND application.
  • Compiled IND maintenance submissions (Annual Reports, Information Amendments, etc.).
  • Key participant in the development of an IND Best Practices Guidance Document
  • Interacted with the Chemistry, Manufacturing, Pharmacology/Toxicology and Clinical departments for IND amendments to FDA.
  • Liaised across teams to facilitate required summary documents for IND development and submission.
  • Developed and managed a comprehensive regulatory submission tracking system for IND submissions.

Show More

10. Regulatory Issues

high Demand

Here's how Regulatory Issues is used in Regulatory Affairs Director jobs:
  • Served as spokesperson for chemical industry legislative and regulatory advocacy and successfully lobbied legislative and regulatory issues impacting the chemical industry.
  • Provide strategic guidance on state and federal telecommunication's regulatory issues.
  • Advised executive management on regulatory issues which resulted in creative strategies.
  • Synthesized complex regulatory issues and advocated key concerns with MSHA, OSHA, and Congress to communicate key issues.
  • Negotiated, coordinated and executed various regulatory issues with RBOC's to include tariff compliance and service fulfillment.
  • Advise the Chief Compliance Officer and Senior Management on a broad range of legal and regulatory issues.
  • Advised member companies on key technical and regulatory issues affecting the industry.
  • Interacted with clients on regulatory issues.
  • Coordinated development of "ONE" Sprint business position on all telecommunication regulatory issues.

Show More

Find which skills are in demand

Skill Page Callout

Jobs With Trending Skills

11. CMC

high Demand

Here's how CMC is used in Regulatory Affairs Director jobs:
  • Provided key CMC regulatory advice and strategy for product development projects.
  • Worked with Pharmaceutical Development and Clinical Operations to formulate CMC strategy.
  • Reviewed/approved product/process changes to ensure compliance with CMC requirements.
  • Author and/or provide CMC support for branded and generic applications for market in the United States, Canada, and Europe.
  • Develop and leverage RA expertise in both CMC and Regional requirements to guide successful product development strategies and supply chain continuity.
  • Manage regulatory projects; determine submission requirements, assess proposed CMC changes for regulatory impact US and Worldwide.
  • Compiled and filed 2 CMC Technical Sections in support of NADA for 2 novel drug products.
  • Research and interpret relevant precedent and maintain files CMC regulatory development issues for BLA3 toxin.
  • Serve as the primary liaison with all external consultants for all regulatory CMC matters.
  • Provide advice on Latin America regional RA CMC requirements influencing product strategy.
  • Provide regulatory assessments for CMC changes and submit updates as required.
  • Prepare CMC responses to health authority questions during development, registration and commercial product lifecycle.

Show More

12. Medical Devices

high Demand

Here's how Medical Devices is used in Regulatory Affairs Director jobs:
  • Managed all regulatory activity related to worldwide marketing of medical devices, including approvals, compliance and quality systems.
  • Developed regulatory and quality strategies for the development and introduction of new medical devices.
  • Participated in relevant trade association and HA sponsored meetings on medical devices.
  • Implemented the pharmacovigilance ensuring the safety and efficacy of medical devices & pharma products.
  • Evaluate the compatibility of trauma reconstructive orthopedic medical devices across multiple device classes and product lines.
  • Manage the ever evolving and complex regulatory requirements for medical devices in Latin American countries.

Show More

13. Regulatory Authorities

high Demand

Here's how Regulatory Authorities is used in Regulatory Affairs Director jobs:
  • Respond to regulatory authorities regarding research protocol modifications and clarifications.
  • Function as a direct contact with regulatory authorities to facilitate the prompt review of submissions.
  • Respond to any and all question from regulatory authorities.
  • Negotiated with state and federal regulatory authorities to define and develop regulations impacting company interests and operations.
  • Interact with representatives of domestic and international partners, subsidiaries and international regulatory authorities to discuss regulatory issues and submission requirements.
  • Assisted regulatory authorities to resolve product acceptance issues, and resolved potential conflicts between installation codes and UL requirements.

Show More

14. Product Development

high Demand

Here's how Product Development is used in Regulatory Affairs Director jobs:
  • Directed research and new product development from concept through initial commercial production for contract manufacturing organization.
  • Accomplished high-throughput, lean registrations through standardization of documentation modules into the product development process.
  • Created and standardized a feasibility worksheet per new product development idea.
  • Facilitate key regional decisions which impact global product development and filing strategies
  • Consult on business logistics, infrastructure and product development.
  • Propose a regulatory component for each product development plan.
  • Managed several New Product Development projects and strategic initiatives.
  • Oversee quality-engineering activities on product development teams.
  • Managed and directed technical activities including basic research, product development, and support for field Technical Service Group.
  • Conceptualized 10 new personal care product ideas and managed 20 new product development projects in personal and pet care.
  • Consult on product development issues.
  • Provided strategic product development, project planning and regulatory consulting for drugproducts on international teams for various clients.
  • Recognize potential regulatory issues in day-to-day activities, from product development through the manufacturing process.
  • Support quality and regulatory functions on the Electrotek product development.
  • Instituted the Stagegate process for product development/project management, served as project leader for all programs.

Show More

15. NDA

average Demand

Here's how NDA is used in Regulatory Affairs Director jobs:
  • Created and worked with product team to submit 3 Orphan Drug Designation (ODD) applications that supported NDA submissions.
  • Provided regulatory support during the NDA review and approval process through to Commercial launch.
  • Led the organization's efforts to compile and submit an NDA in eCTD format.
  • Authored analytical sections of the Company's first NDA (unexpected shortage of staff)
  • Motivated cross-departmental regulatory compliance by coordinating NDA filing regulatory communications meetings.
  • Proofread artworks, labeling components and SPL for NDA, ANDA submission and ensured compliance according to RLD's labeling.

Show More

16. Ensure Compliance

average Demand

Here's how Ensure Compliance is used in Regulatory Affairs Director jobs:
  • Develop and review all curriculum to ensure compliance with federal, state, and local regulatory requirements.
  • Drafted and / or reviewed internal controls to ensure compliance with Gaming Regulations.
  • Drafted key policies to ensure compliance with applicable laws and regulations.
  • Oversee state and federal registrations to ensure compliance.
  • Monitored and assessed regulatory and financial risks of FINRA member broker/dealer firms to ensure compliance with regulatory standards and policies.
  • Drafted the initial, firm-wide ERISA policy and divisional business procedures to increase awareness of regulatory requirements and ensure compliance.

Show More

top-skills
What skills help Regulatory Affairs Directors find jobs?
Tell us what job you are looking for, we’ll show you what skills employers want. Get Started

Online Courses For Regulatory Affairs Directors

One of the best ways to acquire the skills needed to be a regulatory affairs director is to take an online course. We've identified some online courses from Udemy and Coursera that will help you advance in your career. Since regulatory affairs directors benefit from having skills like regulatory agencies, regulatory affairs, and fda, we found courses that will help you improve these skills.

Advertising Disclosure
advertising-disclosure
Practical Regulatory Affairs 2020 - European Medical Devices
udemy
4.5
(293)

A practical course discussing the EU Medical Device Regulation (MDR) in real-world situations...

Principles of Health Law and Regulatory Issues
edX (Global)

This course is part of the Certified Lifestyle Medicine Executive MicroMasters program which consists of 9 courses and a capstone exam. After completing the program, you can also apply to Doane University to complete your MBA online for approximately $10,500 (learn more about the program here). Executives in healthcare systems must have an understanding of healthcare legal and regulatory issues surrounding finance and risk as well as compliance within the law in order to navigate and change...

Regulatory Compliance
coursera

Every organization faces a myriad of risks that can threaten its operations, reputation, and bottom line. A robust, effective compliance program can make the difference between companies that successfully navigate those risks, and those that become cautionary tales. This specialization will introduce the essential elements of effective organizational compliance by exploring the concepts, considerations, and strategies for assessing risks and managing the compliance function. You will learn the f...

FinTech Law and Policy
coursera

Being a successful FinTech firm requires more than just great technology; it also requires an understanding of the laws and regulations applicable to your business. This course will provide you with that understanding. You will learn about the critical legal, regulatory, and policy issues associated with cryptocurrencies, initial coin offerings, online lending, new payments and wealth management technologies, and financial account aggregators. In addition, you will learn how regulatory agencies...

The Simplest Guide to Clinical Data Analysis with SAS
udemy
4.2
(296)

Step into the world of Pharmaceutical industry Clinical Trials Clinical Research Biostatistics Data Management SAS...

Drug Development
coursera

The University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences Drug Development course brings you lectures from both faculty and industry experts. With this course, recorded on campus at UCSD, we seek to share our access to top people in the field who bring an unprecedented range of expertise on drug development. In this course you will learn the different stages of clinical development as well as the regulatory including but not limited to, an Investigational New...

Drug Discovery & Medicinal Chemistry
edX (Global)

Drug discovery is a challenging field, but the pathway most drugs navigate from concept to market is predictable and based upon repeated experimentation. The process requires scientists with expertise in chemistry, biology, and medicine. This course focuses on four aspects of drug development. regulation - approval protocols for government regulatory agencies pharmacodynamics - how a drug affects the body pharmacokinetics - how a drug flows through the body lead discovery/optimization - the...

Financial Regulation in Emerging Markets and the Rise of Fintech Companies
coursera

This course gives an overview of the changing regulatory environment since the 1997 Asian and 2008 global financial crisis. Following these two major crises, governments around the globe enacted a set of far-reaching new financial regulations that are aimed towards safeguarding financial stability. However, banks find it increasingly difficult to be profitable in this new regulatory environment. Technology, at the same time, has taken important leaps forward with the emergence of sophisticated m...

Structure: Building the Frame for Business Growth
coursera

Just like when building a house the foundation for your business provides the framework for success. A business built on weak structure will struggle to succeed. We'll address some of the most pressing issues that you as a business owner must face while constructing the proper framework for your business. Specifically at the end of this course you will be able to: - create and evaluate your company's financial documents; -complete the documents and regulatory procedures to create a legal busines...

Toxicology 21: Scientific Applications
coursera

This course familiarizes students with the novel concepts being used to revamp regulatory toxicology in response to a breakthrough National Research Council Report "Toxicity Testing in the 21st Century: A Vision and a Strategy." We present the latest developments in the field of toxicology-the shift from animal testing toward human relevant, high content, high-throughput integrative testing strategies. Active programs from EPA, NIH, and the global scientific community illustrate the dynamics of...

Nuclear Facilities: Regulations and Licensing
edX (Global)

The first part of the course concentrates on the requirements of operating a nuclear facility – initial licensing process and subsequent continuous regulatory control. Next, we will take a look at the international system of radiological protection and legal framework on nuclear safety, transport and transboundary movement of nuclear material. Finally, we will discuss the issues of illicit nuclear trafficking and nuclear terrorism...

Healthcare Finance, Economics and Risk
edX (Global)

This course is part of the Healthcare Administration MicroMasters program which consists of 7 courses and a capstone exam. After completing the program, you can also apply to Doane University to complete your MBA online for approximately $10,500 (learn more about the program here). In order to be a leader/administrator in thehealthcareindustry, you must have a basic understanding of healthcare finance, risk, legal and regulatory issues in order to navigate and change the system. Managing risk...

Medical Technology and Evaluation
coursera

Innovations in medical technologies are one of the leading areas of economic growth in the world. Whether new technologies take the form of pharmaceutical, medical device, biotechnology, information technology of some combination of these innovations, the opportunities for both private enterprise and social welfare are substantial. However, these innovations are not without cost, and require reimbursement from either a privately or publicly financed health care delivery system to enter the marke...

Health Law, Policy, and Advocacy
edX (Global)

This course is part of the Healthcare Administration MicroMasters program which consists of 7 courses and a capstone exam. After completing the program, you can also apply to Doane University to complete your MBA online for approximately $10,500 (learn more about the program here). To be an effective agent of change, a healthcare administrator must have a foundational understanding of healthcare advocacy, law, and regulatory issues, as well as compliance. This course will focus on a wide range...

Cybersecurity Policy for Aviation and Internet Infrastructures
coursera

In this course we will examine the aviation and Internet infrastructures, and various policies that have been developed to help guide and strengthen their cybersecurity programs. The aviation and Internet infrastructures are also considered "lifeline infrastructure" as part of the transportation and communications sectors. Both subsectors are overseen by the Department of Homeland Security National Protection and Programs Directorate which manages the DHS National Infrastructure Protection Progr...

Accounts Payable Specialist Certification (Exam Cost Included)
ed2go

Accounts Payable Specialist Certification (Exam Cost Included)...

Making a Cell Therapy: Principles and Practice of Manufacturing
edX (Global)

The success of CAR-T cell therapies, driven by their unprecedented efficacy and recent regulatory approvals, has kick-started a new wave of interest into cells as therapies. Yet manufacturing is the link between an exciting new development in the laboratory and a commercial therapy available to the patients who need it. This course will introduce learners to this new field through the following topics. Cellular therapies are living products that are only effective when delivered alive. This...

Administrative Law
ed2go

Administrative Law...

Design and Implementation of Digital Health Interventions
coursera

This course covers various themes around design, regulatory approaches, ethics, technology adoption, implementation and strategy as applied to digital health. These session cover areas to include data regulations, examples of data breaches in digital health, the challenges and opportunities of technology adoption and implementation with a focus on the non-adoption, abandonment, scale-up, spread and sustainability framework (NASSS Framework). The strategy part of this course focuses on understand...

Fintech Overview
edX (Global)

This is the first in a series of courses on financial technology, also called Fintech. The course provides an overview of the most recent technological advances that are radically changing the financial services industry. These technological breakthroughs offer new ways for people to save, invest, borrow, and transact. The course is structured in three modules. In the first module, we will discuss the characteristics and trends in finance and how emerging technologies are changing the financial...

20 Most Common Skill For A Regulatory Affairs Director

Regulatory Agencies13.1%
Regulatory Affairs10.3%
FDA6.8%
Procedures6.4%
Regulatory Strategy5.9%
Global Regulatory5.8%
Regulatory Submissions3.7%
EU2.8%

Typical Skill-Sets Required For A Regulatory Affairs Director

RankascdescSkillascdescPercentage of ResumesPercentageascdesc
1
1
Regulatory Agencies
Regulatory Agencies
13.1%
13.1%
2
2
Regulatory Affairs
Regulatory Affairs
10.3%
10.3%
3
3
FDA
FDA
6.8%
6.8%
4
4
Procedures
Procedures
6.4%
6.4%
5
5
Regulatory Strategy
Regulatory Strategy
5.9%
5.9%
6
6
Global Regulatory
Global Regulatory
5.8%
5.8%
7
7
Regulatory Submissions
Regulatory Submissions
3.7%
3.7%
8
8
EU
EU
2.8%
2.8%
9
9
IND
IND
2.8%
2.8%
10
10
Regulatory Issues
Regulatory Issues
2.6%
2.6%
11
11
CMC
CMC
2.6%
2.6%
12
12
Medical Devices
Medical Devices
2.5%
2.5%
13
13
Regulatory Authorities
Regulatory Authorities
2.3%
2.3%
14
14
Product Development
Product Development
2.3%
2.3%
15
15
NDA
NDA
2.3%
2.3%
16
16
Ensure Compliance
Ensure Compliance
2.1%
2.1%
17
17
Clinical Trials
Clinical Trials
2.1%
2.1%
18
18
R
R
2%
2%
19
19
Regulatory Support
Regulatory Support
1.8%
1.8%
20
20
Direct Reports
Direct Reports
1.6%
1.6%
21
21
Regulatory Activities
Regulatory Activities
1.5%
1.5%
22
22
Regulatory Guidance
Regulatory Guidance
1.4%
1.4%
23
23
Regulatory Filings
Regulatory Filings
1.3%
1.3%
24
24
Business Objectives
Business Objectives
1.3%
1.3%
25
25
ISO
ISO
1.2%
1.2%
26
26
Regulatory Documents
Regulatory Documents
1%
1%
27
27
Oversight
Oversight
0.9%
0.9%
28
28
IDE
IDE
0.8%
0.8%
29
29
PMA
PMA
0.7%
0.7%
30
30
Product Registrations
Product Registrations
0.7%
0.7%
31
31
Business Development
Business Development
0.6%
0.6%
32
32
Annual Reports
Annual Reports
0.6%
0.6%
33
33
CE
CE
0.6%
0.6%
34
34
Regulatory Matters
Regulatory Matters
0.5%
0.5%
35
35
Risk Management
Risk Management
0.5%
0.5%
36
36
Business Units
Business Units
0.5%
0.5%
37
37
GMP
GMP
0.4%
0.4%
38
38
Promotional Materials
Promotional Materials
0.4%
0.4%
39
39
Executive Management
Executive Management
0.4%
0.4%
40
40
MDR
MDR
0.4%
0.4%
41
41
Technical Files
Technical Files
0.4%
0.4%
42
42
QA
QA
0.4%
0.4%
43
43
III
III
0.3%
0.3%
44
44
CFR
CFR
0.3%
0.3%
45
45
CRO
CRO
0.3%
0.3%
46
46
Federal Regulations
Federal Regulations
0.3%
0.3%
47
47
GCP
GCP
0.2%
0.2%
48
48
Usda
Usda
0.2%
0.2%
49
49
Federal Agencies
Federal Agencies
0.2%
0.2%

7,995 Regulatory Affairs Director Jobs

Where do you want to work?