Join us for the “Navigating Your Path: OCRA Career Panel in Regulatory Affairs“, an engaging online workshop designed to illuminate the diverse career paths within the regulatory affairs field. Whether you’re a university student, a healthcare professional looking to transition into regulatory affairs, or a regulatory affairs professional seeking career growth and new opportunities, this event is tailored for you!

Our esteemed panelists, with backgrounds spanning drugs, medical devices, and biologics, will share their unique career journeys and provide invaluable guidance on job hunting, interviewing, and transitioning into regulatory affairs. Gain insights into career development strategies and learn how to achieve long-term success in this dynamic field.

Don’t miss this opportunity to connect with industry experts, ask your burning questions, and take the next step in your regulatory affairs career. Secure your spot today and start navigating your path to success!

Panel

Julie Manchester, RAC, VP, Regulatory Affairs & Quality at Autonomix Medical

Ms. Manchester is a Biotech/Med Device executive with over 15 years of quality and regulatory experience within the medical device, cosmetics, pharmaceutical, and product testing industries.

https://www.linkedin.com/in/juliemanchester

Julie will share with us:

• Career Journey: Transitioning from a chemist and quality manager in laboratories to leadership role in medical device quality and regulatory affairs.
• Key Challenges: Overcoming obstacles when moving from laboratory work to quality and regulatory affairs, and the transferable skills that helped.
• Expectations for Juniors: Essential qualities, skills, and attributes sought when hiring and mentoring junior regulatory professionals.
• Career Growth Strategies: Practical advice for advancing in regulatory affairs, including promotions and career transitions to find the best fit.

Shepard Bentley, RAC, Principal Consultant at Bentley Biomedical Consulting LLC

Shep Bentley is a regulatory affairs consultant with 20+ years’ experience providing regulatory clearances and approvals for devices, drugs and combination products. Offices and affiliations across United States, Canada, Europe, Brazil and Asia.

https://www.linkedin.com/in/shep-bentley-29939a2

Shepard will share with us:

• Technology Transition Experience: Insights on translating early-stage university innovations to real-world products and the role of regulatory affairs in this process.
• Regulatory Experience: Key differences and similarities across pharma, biotech, and medical devices regulatory affair, and considerations for choosing companies and fields early in your career.
• Emerging Opportunities & Trends: Insights into new and evolving career opportunities in regulatory affairs driven by technological innovation.

Paula Lengerke Diaz, MD, Regulatory Manager at 4D Molecular Therapeutics

Paula Lengerke Diaz is a Regulatory Manager at 4D Therapeutics, a clinical-stage biopharma company developing genetic medicines for rare diseases. Trained as a medical doctor in Colombia, she previously served as a Hematology & Oncology Research Fellow at Mayo Clinic and was an associate member at an angel investment firm. Her diverse background bridges medicine, research, and regulatory strategy in the biopharma industry.

https://www.linkedin.com/in/paulalengerke

Paula will share with us:

• Career Journey: Transition from medical doctor, academic researcher to regulatory affairs, leveraging academic and clinical experience.
• Current Job Sharing: Sharing experience as a regulatory manager in the genetic therapy field, overseeing clinical trials and crafting regulatory strategies.
• Job hunting Advice: Job hunting tips, breaking into regulatory affairs, networking strategies, and advice for students and professionals in clinical field exploring alternative careers.

Nora Xi, MS, Regulatory Affair Associate Specialist at Applied Medical

Nora Xi is a Regulatory Affairs Associate Specialist at Applied Medical with 2.5 years of experience in the medical device industry. She holds an M.S. in Regulatory Science from the University of Southern California and a B.S. in Biomedical Engineering from City University of Hong Kong.

https://www.linkedin.com/in/nora-xi-7aa469197

Nora will share with us:

• Landing first regulatory affair job as an International Student – how to overcome language and job sponsorship challenges.
• Job Hunting & Interview Success – Resume, interviews, and LinkedIn tips for securing internship and full-time jobs in regulatory affair field.
• The Power of Networking – How to network and get involved in professional organizations for long-term career growth.

Date: Wednesday | April 2, 2025

Time: 6:30pm – 8pm PT

Location: Zoom

Registration: Free for OCRA-DG members and nonmembers

Topic: OCRA Career Panel

Register Now