Regulatory Affairs, Ethics, Compliance

Introductory Resources

• What is Regulatory Affairs?, Regulatory Affairs Professional Society (RAPS).
• Career Story – From the bench to regulatory affairs, Science.
• A day in the life of a scientific regulatory manager, Science.
• Why working in regulatory means seeing the big picture, 6-min video.
• Career story – from chemistry to regulatory affairs (at about 44 mins in the video).
• Exploring jobs (general job description, skills, etc.), BU Vault:
  • Regulatory Affairs Managers.
  • Regulatory Affairs Specialists.
  • Compliance Managers.
  • Technical Ethicists.
  • Medical Ethicists.
• Manager of Scientific and Regulatory Affairs video interview, Candid Career.
• Senior Manager of Regulatory Compliance video interview, Candid Career.

Venturing further in this career area

• The PhD Scientists Pathway into Regulatory Affairs, Laura DiMichele, PhD, RAC, CCRP.
• Working in Regulatory Affairs – Roles, Career progression, Salaries, Trends, Northeastern University.
• Learn more about Regulatory Core Competencies with these RAPS reports.
• Exploring labor market trends and insights – Choose “Find Career Data By Selecting Networks” and search for “Regulatory Affairs…” jobs.

Learning by doing job-related tasks

Job Simulations are job-related tasks that can be completed in a few hours, to help you assess how enjoyable and how much of a good fit a specific job could be for you. Intersect Job Simulations have been created by PhDs for PhDs, to support their career transitions into a wide range of careers. To make the most of job simulations, please set up SMART Goals to perform each simulation in a reasonable timeline. When you have completed the task, fill out the Self-Reflection Sheet, which will help you reflect on what you enjoyed (or did not enjoy) about the simulation, and how it can help inform your career exploration efforts.

• Regulatory Affairs Job Simulation – Performing a Competitive Analysis.
• Explore regulatory training videos from ReGARDD (Regulatory Guidance for Academic Research of Drugs and Devices).
• The Duke University School of Medicine ORAQ provides education and training to people interested in learning more about FDA regulations and ways to transition into Regulatory Affairs roles. They also provided recordings of past ORAQ webinars and events on YouTube.

Preparing your transition into this career area

• Focus on your skills, Nature article.
• Explore fellowship programs supporting career transitions into regulatory affairs:
  • Regulatory Affairs Fellowship, Harvard MIT Center for Regulatory Science.
  • Companies like Vertex, GSK (GSK Global Regulatory Affairs Fellowship), as well as the Food and Drug Administration (FDA Regulatory Pharmaceutical Fellowship) have fellowships to help PhD and/or MD graduates transition into a regulatory affairs career.
• Explore and connect with members of the following professional societies:
  • Regulatory Affairs Professional Society, RAPS.
  • The Organization for Professional in Regulatory Affairs, TOPRA.
• Growing your network and having informational interviews with PhDs who have transitioned into careers of interest to you will enable you to learn more about the job’s daily responsibilities, hiring process, career progression, etc., and the sector as a whole.
  • Look for and join relevant thematic groups on LinkedIn, online communities, etc.
  • Look for GMS Alumni who have transitioned into this career area, or connect with an RA professional from the Social Scientist mentoring network.
• Analyze job descriptions to learn more about what institutions and organizations are currently looking for.
• Study company websites, follow them on social media and YouTube, and join Regulatory Affairs networks on LinkedIn (e.g., San Diego Regulatory Affairs Network).