Position Summary
Responsible for leading regulatory review of advertising, promotional, and other external communications to ensure compliance with applicable regulatory requirements. Oversees product labeling development, review, and maintenance; provides regulatory guidance through the MLR review process. Partners cross-functionally to support timely approval and distribution of promotional/disease-state materials; serves as primary liaison with the FDA Office of Prescription Drug Promotion (OPDP); contributes to labeling strategies across the portfolio.
Primary Responsibilities
- Lead development/oversight of processes for creation, review, and approval of advertising/promotional materials within MLR and other external communications.
- Review external communications, sales/marketing materials, and training for compliance.
- Advise senior management on regulatory strategy and risk analysis tied to commercial strategy.
- Participate in training for sales and marketing on advertising/promotional materials.
- Represent the company to customers/agencies; present on regulatory issues related to advertising/promotional activities.
- Other responsibilities as assigned.
Qualifications/Skills
- Bachelor’s degree in a scientific discipline or related field; MBA preferred.
- ~10 years progressively responsible Regulatory Affairs experience focused on advertising/promotional regulations.
- Experience communicating/negotiating with OPDP; perform risk assessment.
- Proven experience developing/executing complex global regulatory strategies; assess/communicate risk/benefit to senior management.
- Labeling development and lifecycle management experience.
- Experience negotiating with regulatory authorities.
- Organizational and matrix management experience.
- Thorough knowledge of US and international pharmaceutical regulations.
- Strong problem-solving/conflict resolution; excellent written/verbal communication.
- Strong collaboration in cross-functional/global teams; ability to negotiate and influence senior leaders.
- Ability to travel domestically and internationally.
Benefits/Compensation (as stated)
- Discretionary bonus and equity awards; Salary range: $193,400–$241,800.
- Medical/dental/vision; 401(k) match 1:1 up to 5%; equity and other listed benefits.
Location/Work Model
San Diego, CA; Princeton, NJ; or San Francisco, CA. Hybrid—average 3 office days/week.