Regulatory Ad/Promo Lead - Associate Director, Biopharma

Neurocrine Biosciences; San Diego (CA); On-site; USD 174,000 - 238,000; Full time

Benefits offered by this job

Annual bonus (30% target)

Health, dental, vision insurance

401(k) with company match

Paid vacation & holidays

Job summary

Neurocrine Biosciences seeks a lead reviewer for medical education and promotional materials. You will steer cross-functional reviews to ensure timely, compliant submissions to OPDP and FDA; support strategic direction for Regulatory Ad Promo and optimize processes.

You will assess FDA guidance, advise on labeling changes, and manage communications with regulatory management, mentoring junior staff. This role is based in San Diego and requires extensive Regulatory Affairs expertise.

Qualifications

• BS/BA in Life/Health Sciences or related field with 10+ years in Regulatory Affairs in biotech/pharma/device.
• Or Master’s in Life/Health Sciences with 8+ years of similar Regulatory experience.
• Strong communication, problem-solving, analytical thinking and influencing skills.
• Proven track record in Advertising & Promotional review committees and FDA guidance.

Responsibilities

• Lead regulatory reviews for advertising and promotional materials across products and disease states.
• Collaborate with PRC, MRC and field medical teams to ensure compliant submissions.
• Monitor FDA guidance and regulatory environment; communicate risks to Sr. Leadership.
• Develop partnerships between Regulatory Affairs, PRC and MRC partner functions.
• Ensure promotional claims align with approved registrations and labeling.
• Mentor junior staff and maintain SOPs and department practices.

Skills

Regulatory Affairs

Advertising & Promotion

FDA guidelines

Communication skills

Independent work

Education

BS/BA Life/Health Sciences or related field

Master’s in Life/Health Sciences or related field

Tools

Veeva Vault / similar

Microsoft Office

Adobe Professional

Job description

Neurocrine Biosciences seeks a lead reviewer for medical education and promotional materials. You will steer cross-functional reviews to ensure timely, compliant submissions to OPDP and FDA; support strategic direction for Regulatory Ad Promo and optimize processes.

You will assess FDA guidance, advise on labeling changes, and manage communications with regulatory management, mentoring junior staff. This role is based in San Diego and requires extensive Regulatory Affairs expertise.