(Senior) Director, Regulatory Affairs, Advertising, Promotion & Labeling - Proclinical Staffing

(Senior) Director, Regulatory Affairs, Advertising, Promotion & Labeling – Permanent – San Francisco Bay Area

Proclinical is seeking a (Senior) Director, Regulatory Affairs - Advertising, Promotion & Labeling for a growing biopharmaceutical company located in the San Francisco Bay Area, California.

Primary Responsibilities:

In this role, you will serve as the regulatory labeling and promotion expert and together with legal and applicable stakeholders, ensure that promotional practices are consistent with applicable regulatory requirements, guidelines, company policies, and procedures. Together with the Regulatory Affairs team and in close collaboration with other departments, the Director / Senior Director, Labeling, Advertising, and Promotion will take a hands-on approach to providing the necessary reviews and support for their projects in rare diseases.

The position is based in the San Francisco Bay Area (California) in a hybrid work schedule (preferred) or remote based (must be West Coast US based).

Skills & Requirements:

• A degree in life science, chemistry, or chemical engineering or closely related discipline with a graduate degree (e.g., PharmD) preferred and at least 10 years of experience in labeling and adverting/promotion activities. Experience in a small company and in a fast-paced environment is strongly preferred.
• Demonstrated in-depth knowledge of promotional regulations and guidance as well as standards and best practices.

The (Senior) Director, Regulatory Affairs, Advertising, Promotion & Labeling will:

• Accountable for oversight of the labeling process for all programs from development through commercialization globally.
• Provide regulatory input and guidance to relevant stakeholders regarding marketing strategies, promotion objectives, and plans.
• Provide regulatory input on concept plans through draft materials. Serve as primary Regulatory reviewer and approver of all labeling and promotional materials
• Review and approve all promotional materials
• Serve as regulatory representative on MRC and PRC
• Serve as primary regulatory liaison to FDA’s Office of Prescription Drug Promotion
• Propose creative and compliant regulatory strategies and solutions to unique or challenging promotional concepts that balance business objectives and regulatory risk
• Develop and maintain target product profile, company core datasheet, patient labeling, USPI, and summary of product characteristics or equivalents internationally

If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.