Job Title: Director, Regulatory Affairs, Advertising and Promotion
Job Responsibilities:
- Lead the regulatory review process as a member of a multidisciplinary medical, legal, and regulatory review team for promotional and medical communications of products within the assigned therapeutic area, ensuring compliance with FDA regulations, guidance, and company policies.
- Act as a subject matter expert on FDA regulations, guidance, enforcement trends, and policy issues relevant to promotion and labeling.
- Serve as a strategic partner to internal stakeholders, including Commercial, Medical Affairs, Corporate Communications, Legal, and Compliance, providing regulatory guidance and perspectives on key business strategies, objectives, and tactics.
- Propose creative, effective, and compliant strategies and solutions to challenging promotional concepts that meet business objectives and mitigate regulatory risk.
- Provide promotional regulatory input on concepts and draft materials to ensure alignment with FDA regulations, guidance, and company policies.
- Act as the primary point of contact with the Office of Prescription Drug Promotion (OPDP) for the company's products within their therapeutic area on matters related to advertising and promotional materials.
- Manage interactions with OPDP, including responses to regulatory inquiries, requests for advisory comments, and necessary discussions with OPDP.
- Oversee the preparation and timely submission of regulatory documents related to promotional materials, including Form FDA 2253 submissions.
- Provide strategic guidance on product development and label development strategies to ensure promotional claims can be supported and align with the company's strategic imperatives.
- Maintain up-to-date knowledge of current regulations, industry trends, and internal systems. Ensure all activities comply with regulatory requirements, internal policies, and industry standards.
- Mentor junior members of the Regulatory Advertising and Promotions/Labeling team and foster their development through sharing knowledge and providing feedback.
Education and Experience Information:
- Bachelor’s degree in Life Sciences or a related field. Advanced degrees (PharmD, PhD, MS, MBA, JD) are preferred.
- Minimum of 10+ years of experience in regulatory affairs within the pharmaceutical or biotechnology industry, with at least 5 years of experience specific to Regulatory Affairs – Advertising and Promotion.
- Launch experience or experience managing regulatory advertising and promotion filings (., launch advisory comment submission or responses to enforcement letters) is highly desirable.
- Ability to understand and interpret clinical trial data.
- Expert understanding of FDA promotional regulations, product, and therapeutic knowledge as well as evidentiary standards required to support product claims.
- Excellent oral and written communication skills with the ability to clearly and concisely articulate regulatory risk to internal stakeholders.
- Demonstrated history of applying in-depth knowledge of FDA regulations, industry guidelines, and best practices related to advertising, promotion, and labeling into regulatory guidance provided to internal stakeholders.
- Ability to spot issues and offer innovative and compliant solutions to mitigate risks.
- Excellent negotiation and project management skills. Ability to influence cross-functional teams and drive strategic initiatives.
- Occasional travel may be required based on business needs.
Salary Information:
- Not provided in the text.
Core Values:
- Let people be their best
- Respect one another and act as one
- Learn, adapt, and win
- Know someone’s health is in our hands
- Own the solution and make it happen
Legal Terminology:
The position requires adherence to FDA regulations, guidance, and company policies. The candidate must maintain up-to-date knowledge of current regulations and ensure compliance with regulatory requirements, internal policies, and industry standards. The company is an equal opportunity employer, providing a workplace free from discrimination, considering all qualified applicants and employees without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law. Applicants requiring accommodations in connection with the hiring process or to perform the essential functions of the position should contact the company's Talent Acquisition team.
Equal Opportunity Employer:
This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, applicants should review the Know Your Rights notice from the Department of Labor.
