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Regulatory affairs manager skills for your resume and career

Updated January 8, 2025
6 min read
Regulatory affairs manager example skills
Below we've compiled a list of the most critical regulatory affairs manager skills. We ranked the top skills for regulatory affairs managers based on the percentage of resumes they appeared on. For example, 10.9% of regulatory affairs manager resumes contained regulatory affairs as a skill. Continue reading to find out what skills a regulatory affairs manager needs to be successful in the workplace.

15 regulatory affairs manager skills for your resume and career

1. Regulatory Affairs

Regulatory affairs entail a set of rules, regulations, and enforcement guiding the operations and conduct of a company business, organization, or association.

Here's how regulatory affairs managers use regulatory affairs:
  • Integrated regulatory affairs department responsibilities following corporate acquisition of Cadence Pharmaceuticals.
  • Manage regulatory affairs specialists and administrators

2. FDA

The Food and Drug Administration (FDA) is a division of the US Department of Health and Human Services that regulates the production and sale of food, pharmaceutical products, medical equipment, and other consumer goods, as well as veterinary medicine. The FDA is now in charge of overseeing the manufacture of products like vaccines, allergy treatments, and beauty products.

Here's how regulatory affairs managers use fda:
  • Managed an operational team ensuring timely regulatory submissions to FDA in a department of approximately 30 regulatory professionals.
  • Worked in a pharmaceutical repackaging environment and provided oversight and application of FDA standards to the repackaging process.

3. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how regulatory affairs managers use medical devices:
  • Established and implemented domestic and international import-export procedures based on FDA regulations for medical devices and components.
  • Developed regulatory strategies related to marketing potential for pharmaceuticals, contrast media and respiratory medical devices.

4. Regulatory Submissions

Regulatory Submissions offers a readable and clearly written road map for effective submission of documents for required regulatory reviews during product development.

Here's how regulatory affairs managers use regulatory submissions:
  • Managed comprehensive regulatory submission processes including product license and manufacturing/processing license applications.
  • Define CMC content (data and documentation) requirements for regulatory submissions and review this content for conformance with established requirements.

5. Regulatory Agencies

A regulatory agency is a Public Benefit Corporation (PBC) that is responsible for supervising certain human activities and controlling them to some extent. They are set up in some areas such as hospitals, law firms, and governmental setup to regulate safety standards. They prevent undue and unjust abuse of power in these setups.

Here's how regulatory affairs managers use regulatory agencies:
  • Planned, developed and presented environmental legislative and regulatory initiatives for Congress, state legislatures, federal and state regulatory agencies.
  • Investigated and resolved compliance problems, questions or complaints received internally within Moore Medical, from customers or government regulatory agencies.

6. Global Regulatory

The authority that safeguards and promotes industry standards in the US and worldwide is termed as a global regulatory authority.

Here's how regulatory affairs managers use global regulatory:
  • Developed global regulatory strategies for candidate drug products based on knowledge of U.S. and international regulatory requirements.
  • Follow up with global regulatory teams on Health Authority updates and communications for packaging implementation deadlines.

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7. Regulatory Strategies

Regulatory strategies depict the approaches used to control and implement effective policies relevant to resolving various human services issues. Regulatory strategies guide the development and implementation of policies that influence the quality of services offered to the public's members.

Here's how regulatory affairs managers use regulatory strategies:
  • Scan the external environment and work with external associations to proactively adapt regulatory strategies and influence change within areas of responsibility.
  • Established regulatory strategies, infrastructure, and country-specific sponsorship and representation for both domestic and international product distribution.

8. Project Management

Here's how regulatory affairs managers use project management:
  • Provided submission project management also regulatory documentation publishing expertise to review, approve, coordinate and communicate with clinical study teams.
  • Provided key coordinating/project management role for approval of new products and support of marketed products.

9. Regulatory Compliance

Here's how regulatory affairs managers use regulatory compliance:
  • Oversee all functions of regulatory compliance internally, including auditing, training, documenting processes and file preparation for regulatory auditing.
  • Suggest and debate alternative methods and procedures in solving problems and meeting changing market opportunities, while maintaining essential regulatory compliance.

10. EU

Here's how regulatory affairs managers use eu:
  • Prepared and coordinated efforts to begin EU Cosmetics Registration.
  • Work with EU Consultants and Safety Assessors in creating Product In Files (PIF) and Safety Assessments for all products.

11. Product Development

Product development is the complete procedure of creating a product from concept until release of the final product. Product development has many stages after which a product is released into the market. Identifying the need, creating the opportunity, conceptualizing a product, and providing a solution, all are different stages of product development.

Here's how regulatory affairs managers use product development:
  • Performed quality audits of critical suppliers, provided quality and regulatory services and guidance to new product development teams.
  • Support Product Development department, Customer Service and Manufacturing to provide technical service on formulations to meet customer requirements.

12. Regulatory Authorities

Regulatory authorities refer to the government organizations created to oversee the policies and procedures enforced in various branches of law. Some examples of these include the Food and Drug Administration, the Federal Trade Commission, and the Bureau of Alcohol, Tobacco, and Firearms. Each of these administrations ensures health and safety regulations put in place by the government are enforced in all appropriate situations.

Here's how regulatory affairs managers use regulatory authorities:
  • Prepared responses to deficiency letters or requests for information from regulatory authorities or inquiries from internal and third party customers.
  • Negotiated with state and federal regulatory authorities to define and develop regulations impacting company interests and operations.

13. NDA

A non-disclosure agreement, also called a confidentiality agreement, refers to the constitutional paperwork that compels two parties to keep each other's data fully confidential. Trade secrets and different types of sensitive data are kept secure via an NDA. If one party doesn't keep up his end of the bargain, they will break the law and may face charges.

Here's how regulatory affairs managers use nda:
  • Coordinated regulatory transfer of NDA and IND to ex-US corporate entity and assumed role as US Agent.
  • Authored and managed global submission activities for the organization, including IND and NDA filings.

14. Regulatory Issues

Regulatory Issues refer to the potential risks that local legislations or regulations will change, which businesses must conform to. If a business does not comply with the changes made, there could be cause for legal action. Examples of regulatory issues include new stimulus bills, changes to workers' leave, and reforms to overarching issues such as healthcare.

Here's how regulatory affairs managers use regulatory issues:
  • Collaborated with trade associations and government agencies to identify and prioritize key regulatory issues and develop cost effective compliance strategies.
  • Develop regulatory strategy and address regulatory issues that arise at a more advanced stage of device development.

15. IND

IND which stands for "Investigational New Drug" are drug applications submitted to the Food and Drug Administration (FDA). Some IND is submitted to start clinical trials to gain marketing approval for commercial purposes while others are purely research-oriented to study an unapproved drug for a patient population or new evidence.

Here's how regulatory affairs managers use ind:
  • Performed IND submission and clearance without issues for new abuse-deterrent analgesic product.
  • Prepared regulatory filings for medical device (510(k)) and pharmaceutical products (IND, DMF).
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List of regulatory affairs manager skills to add to your resume

Regulatory affairs manager skills

The most important skills for a regulatory affairs manager resume and required skills for a regulatory affairs manager to have include:

  • Regulatory Affairs
  • FDA
  • Medical Devices
  • Regulatory Submissions
  • Regulatory Agencies
  • Global Regulatory
  • Regulatory Strategies
  • Project Management
  • Regulatory Compliance
  • EU
  • Product Development
  • Regulatory Authorities
  • NDA
  • Regulatory Issues
  • IND
  • CMC
  • Regulatory Guidance
  • Excellent Interpersonal
  • ICH
  • Health Authorities
  • Clinical Trials
  • Regulatory Support
  • ISO
  • ECTD
  • Lifecycle Management
  • Regulatory Filings
  • Regulatory Bodies
  • International Regulations
  • III
  • Quality System
  • Pharmaceutical Industry
  • Regulatory Risk
  • Promotional Materials
  • QA
  • Direct Reports
  • Due Diligence
  • PMA
  • MDR
  • Product Registrations
  • GMP
  • IDE
  • Cycle Management
  • Management System
  • MDD
  • CFR
  • Business Development
  • R

Updated January 8, 2025

Zippia Research Team
Zippia Team

Editorial Staff

The Zippia Research Team has spent countless hours reviewing resumes, job postings, and government data to determine what goes into getting a job in each phase of life. Professional writers and data scientists comprise the Zippia Research Team.

Updated January 8, 2025

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