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Regulatory affairs associate skills for your resume and career

Updated January 8, 2025
7 min read
Below we've compiled a list of the most critical regulatory affairs associate skills. We ranked the top skills for regulatory affairs associates based on the percentage of resumes they appeared on. For example, 11.5% of regulatory affairs associate resumes contained regulatory affairs as a skill. Continue reading to find out what skills a regulatory affairs associate needs to be successful in the workplace.

15 regulatory affairs associate 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 associates use regulatory affairs:
  • Developed procedures to ensure regulatory compliance, and supporting the extended Regulatory Affairs team with preparation of regulatory filling and amendments.
  • Maintained Global Regulatory Affairs Portal, updated project folders and assisted in the implementation of an archiving/document management system.

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 associates use fda:
  • Reviewed and prepared documents in compliance with FDA and foreign regulations for an international dental supply manufacturer.
  • Perform electronic processing/publishing of applications for submission through the FDA s Electronic Systems Gateway, utilizing GlobalSubmit.

3. 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 associates use regulatory submissions:
  • Format documents intended for regulatory submissions in accordance with company style manual to ensure they meet requirements for electronic submissions.
  • Identify, obtain, compile and review regulatory documents for regulatory submissions, striving for quality submissions and expedited approvals.

4. Medical Devices

Medical devices refer to apparatus for use in medical procedures.

Here's how regulatory affairs associates use medical devices:
  • Authored regulatory opinion white paper to determine the best regulatory route for medical devices seeking approval prior to commercialization.
  • Researched, wrote and edited medical literature reviews and communications material to support international marketing of medical devices.

5. 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 associates use global regulatory:
  • Develop detailed understanding of regulatory guidelines and technical requirements in assigned countries and a broad understanding of the global regulatory environment.
  • Developed processes to ensure regulatory compliance with domestic and global regulatory filing requirements and conducted quality check of completed work.

6. 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 associates use regulatory agencies:
  • Support efforts per the direction of the international regulatory agencies, sister companies and international distributors regarding registrations and licenses.
  • Coordinated the manual preparation of technically and scientifically complete document packages for submission to regulatory agencies worldwide.

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7. Regulatory Risk

Here's how regulatory affairs associates use regulatory risk:
  • Assessed regulatory risk of product design, labeling, and packaging changes throughout the life cycle of the product.
  • Assessed and reduced regulatory risks and provided innovative ways to approve critical promotional materials.

8. Project Management

Here's how regulatory affairs associates use project management:
  • Provided regulatory guidance to other departments including manufacturing, quality control, supply and logistics, project management and clinical research.
  • Performed document coordination and participated in project management activates, communication and appropriate escalations.

9. Regulatory Strategy

Here's how regulatory affairs associates use regulatory strategy:
  • Research responses to anticipated FDA/panel questions, prepared slide responses reflecting regulatory strategy, statistical rationale and data methodology.
  • Researched, assessed, and summarized regulatory intelligence for senior personnel to aid them in developing regulatory strategy.

10. ECTD

Here's how regulatory affairs associates use ectd:
  • Audited regulatory notifications and impacted eCTD Module 3 sections, ensuring precision with strict attention to detail, correcting as required.
  • Helped prepare & maintain FDA submitted regulatory documents with a team of others, as well as place them in eCTD.

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 associates use product development:
  • Cross-trained in operational and new product development activities including method/process validation, customer service, budget planning, strategic planning.
  • Provided input for regulatory requirements and regulatory strategies in interdepartmental meetings on product development to ensure timely submission and approval.

12. ICH

Here's how regulatory affairs associates use ich:
  • Maintain awareness of all FDA/GCP and ICH changes in regulations and forms.
  • Provided strategic input for projects as required according to ICH and CGMP and guidelines to Clinical Operations team guided by timelines.

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 associates use nda:
  • Provided regulatory guidance, preparation and submission of CMC sections for IND, NDA, ANDA and supplemental filings.
  • Reviewed IND and NDA applications including responsibility for safety reporting requirements, amendments, supplements, and annual reports.

14. Regulatory Support

Here's how regulatory affairs associates use regulatory support:
  • Provide regulatory support for the review and approval of labeling, advertising and promotional materials.
  • Provide regulatory support for project life cycle process of marketed product/project for SkinCare division.

15. Pharmaceutical Industry

Here's how regulatory affairs associates use pharmaceutical industry:
  • Participated in cross functional team members meetings for improvements in regulatory department and maintain knowledge of current trends in pharmaceutical industry.
  • Fielded all manner of inquiries from Trial Monitors (who represent pharmaceutical industry research sponsors) during their site visits.
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List of regulatory affairs associate skills to add to your resume

Regulatory affairs associate skills

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

  • Regulatory Affairs
  • FDA
  • Regulatory Submissions
  • Medical Devices
  • Global Regulatory
  • Regulatory Agencies
  • Regulatory Risk
  • Project Management
  • Regulatory Strategy
  • ECTD
  • Product Development
  • ICH
  • NDA
  • Regulatory Support
  • Pharmaceutical Industry
  • EU
  • CMC
  • IND
  • Regulatory Guidance
  • Investigational
  • Regulatory Authorities
  • Safety Reports
  • Regulatory Issues
  • ISO
  • Clinical Trials
  • CFR
  • III
  • Health Authorities
  • Data Entry
  • Regulatory Filings
  • Informed Consent
  • Cycle Management
  • GMP
  • IRB
  • SharePoint
  • QC
  • QA
  • Regulatory Guidelines
  • Promotional Materials
  • Lifecycle Management
  • GCP
  • PMA
  • Federal Regulations
  • Regulatory Compliance
  • Proofreading
  • DMF
  • Drug Products

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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