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Regulatory affairs director skills for your resume and career

Updated January 8, 2025
6 min read
Regulatory affairs director example skills
Below we've compiled a list of the most critical regulatory affairs director skills. We ranked the top skills for regulatory affairs directors based on the percentage of resumes they appeared on. For example, 12.6% of regulatory affairs director resumes contained regulatory affairs as a skill. Continue reading to find out what skills a regulatory affairs director needs to be successful in the workplace.

15 regulatory affairs director 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 directors use regulatory affairs:
  • Selected by senior leadership to participate in the Abbott Regulatory Council key business initiative program to improve Regulatory Affairs across Abbott.
  • Served as primary regulatory affairs leader for registration and compliance of pharmaceuticals and medical devices related to pain relief.

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 directors use fda:
  • 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.

3. Regulatory Strategy

Here's how regulatory affairs directors use regulatory strategy:
  • 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.

4. 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 directors use global regulatory:
  • 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.

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 directors use regulatory agencies:
  • 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.

6. 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 directors use regulatory submissions:
  • Support the preparation of scientifically sound Regulatory submissions in line with requirements and company policies and procedures.
  • Review and determine the applicability of supporting documentation for inclusion in Regulatory submissions.

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7. EU

Here's how regulatory affairs directors use eu:
  • 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.

8. 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 directors use ind:
  • Edited collaborators regulatory filings including Appendix M and initial IND application.
  • Compiled IND maintenance submissions (Annual Reports, Information Amendments, etc.).

9. 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 directors use regulatory issues:
  • 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.

10. CMC

CMC stands for "chemistry, manufacturing, and controls," which represents a standard procedure when producing new pharmaceutical drugs. First the drug is developed through chemical tests and analysis, then the drug is manufactured. Before the pharmaceutical can be offered to the public, it must be tested on individuals, often animal test subjects first and then human beings. This allows pharmacists to determine whether the drug must be reconsidered, reproduced, or whether any side effects accompany the drug.

Here's how regulatory affairs directors use cmc:
  • Worked with Pharmaceutical Development and Clinical Operations to formulate CMC strategy.
  • Provided key CMC regulatory advice and strategy for product development projects.

11. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how regulatory affairs directors use medical devices:
  • 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.

12. 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 directors use product development:
  • 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.

13. 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 directors use regulatory authorities:
  • 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.

14. 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 directors use nda:
  • 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.

15. Regulatory Support

Here's how regulatory affairs directors use regulatory support:
  • Provided regulatory support to Product Engineering Department to create, update, and maintain Design History Files.
  • Provide regulatory support for the development of dermatologic products.
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List of regulatory affairs director skills to add to your resume

Regulatory affairs director skills

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

  • Regulatory Affairs
  • FDA
  • Regulatory Strategy
  • Global Regulatory
  • Regulatory Agencies
  • Regulatory Submissions
  • EU
  • IND
  • Regulatory Issues
  • CMC
  • Medical Devices
  • Product Development
  • Regulatory Authorities
  • NDA
  • Regulatory Support
  • Regulatory Compliance
  • Clinical Trials
  • Cycle Management
  • Direct Reports
  • Regulatory Guidance
  • Regulatory Filings
  • Business Objectives
  • ISO
  • ECTD
  • Regulatory Risk
  • IDE
  • PMA
  • Product Registrations
  • CE
  • Business Development
  • Risk Management
  • GMP
  • Executive Management
  • Promotional Materials
  • MDR
  • Clinical Studies
  • QA
  • III
  • CFR
  • CRO
  • Federal Regulations
  • GCP
  • USDA
  • Government Agencies
  • PET

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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