Foster City

POSTION SUMMARY

The Director, Regulatory Affairs Advertising/Promotion will provide leadership, insight, and clear direction on all advertising and promotional programs and tactics that are compliant with regulations, aligned with approved product registrations, and company policies throughout the product life cycle. The Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Compliance, Commercial and International distributors and will serve as a key member of the Medical/Legal/Regulatory (MLR) Review Committee. This role will report to the Head of Commercial Regulatory Affairs & Labeling (Executive Director).

JOB FUNCTIONS/RESPONSIBILITIES

• Responsible for providing regulatory advertising/promotion leadership for assigned programs of marketed and investigational products in US and international regions.
• Conduct review and approval of advertising/promotional materials as the lead regulatory reviewer on the MLR Committee for US and international markets.
• Serve as the primary regulatory liaison to FDA/CDER/OPDP.
• Author regulatory submissions (Form 2253) and work closely with the publishing vendor to ensure timely submission of promotional materials to the Office of Prescription Drug Promotion (OPDP).
• Represent Regulatory Advertising/Promotion at labeling meetings and provide informed strategic regulatory guidance, as appropriate.
• Provide regulatory guidance on new promotional or disease awareness concepts and new campaigns that may be related to Mirum products.
• Maintain a continued awareness and understanding of FDA and international (e.g., EU and ROW) Health Authority regulations, guidance documents, and enforcement actions with regards to advertising and promotion of pharmaceutical products. Monitor enforcement trends and provide timely advice to the team.
• Serve as an expert resource for regulatory advertising/promotion advice across departments.
• May contribute to process improvements relevant to commercial regulatory activities, including the MLR Committee.
• Responsible for the development and implementation of regulatory advertising/promotional processes, as necessary.
• Support as needed for product labeling activities.

QUALIFICATIONS

Education/Experience:

• Bachelor’s or advanced degree in a biological or life sciences or related scientific discipline (pharmacy or medicine); an advanced degree is desirable.
• A minimum of 10 years of biopharmaceutical industry experience, with a minimum of 8 years of experience in the regulatory review of advertising/promotional materials for prescription drug and/or biologic products.
• Experience representing Regulatory Affairs Advertising/Promotion on cross functional teams.
• Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Excellent communication skills both verbal and in writing.

Knowledge, Skills and Abilities:

• Direct experience with FDA’s Office of Prescription Drug Promotion (OPDP) submissions and strategies. Experience with international (e.g., EU and ROW) Health Authorities is desirable; demonstrated contact through a CRO is acceptable.
• Extensive in-depth knowledge of regulatory requirements associated with advertising and promotion of prescription drug products, and experience in applying such requirements is required.
• Experience with global rules and regulations regarding promotion of medical products is highly desirable.
• Excellent verbal, written, negotiation, influence and interpersonal communication skills required.
• Capable of critically reviewing complex technical/scientific documents and influencing colleagues across functions. Demonstrated ability to analyze and interpret efficacy and safety data is critical.
• Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others. Must be self-directed and proactive.
• Ability to engage multiple stakeholders to achieve the business objective, while building excellent working relationships.
• Strong team player that has a customer service approach and is solution oriented.

Work Environment:

• This is a high growth, fast paced organization. The ability to be productive and successful in such a work environment is critical.
• Some travel required. Responsibilities may require a work schedule that may include working outside of “normal” work hours in order to meet business demands in a company with activities taking place around the globe.