Associate Director, Regulatory Affairs - Advertising and Promotion

Insmed Incorporated

12d • $164,000 - $213,000 • Remote

About The Position

At Insmed, every moment and every patient counts — and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases, you’ll be part of a community that prioritizes the human experience, celebrates curiosity, and values every person’s contributions to meaningful progress. That commitment has earned us recognition as Science magazine’s No. 1 Top Employer for five consecutive years, certification as a Great Place to Work® in the U.S., and a place on The Sunday Times Best Places to Work list in the UK. For patients, for each other, and for the future of science, we’re in. Are you? About the Role: We’re looking for an Associate Director, Regulatory Affairs – Advertising and Promotion to help us expand what’s possible for patients with serious diseases. Reporting to the Executive Director, Regulatory Ad Promo & Intelligence Initiatives, the Associate Director will review and approve advertising and promotional materials, related training, and other nonproduct commercial communications, medical materials, and publications. Additional responsibilities will include monitoring regulatory compliance trends in industry and interpreting new and updated regulations and guidance documents for both labeling and promotion. The Associate Director, Regulatory Affairs – Advertising and Promotion will also coordinate training pertaining to advertising, promotion, and product launch activities. The individual will work collaboratively with medical affairs, legal, compliance, and commercial teams in the development and implementation of advertising and promotional processes and materials for product portfolio.

Requirements

• You must have at least a Bachelor’s degree in a relevant/scientific discipline and 7+ years’ experience working in the pharmaceutical or biotech industry.
• 5+ years working in the advertising and promotional review space.
• Experience working with OPDP and with post market FDA submissions.
• Thorough knowledge of US regulatory requirements pertaining to marketing authorization filings for new products or updates to existing products particularly related to advertising and promotion.
• Knowledge of US regulations for labeling.
• Ability to assess areas of regulatory risk and effectively communicate and coordinate discussions to influence all business functions to reach resolution.
• Strong writing, project management, and communication skills.
• Proven ability to thrive in a fast-paced environment.
• Strategic problem solver with strong collaboration skills.

Nice To Haves

• Graduate degree preferred.
• Awareness of global drug/biologic regulations and standards particularly related to promotion including EU and international requirements.

Responsibilities

• Represent Regulatory Affairs as part of cross-functional commercial review committee, providing regulatory input into the review and approval of promotional and nonpromotional materials.
• Maintain a deep and current awareness of evolving US regulations, codes and guidelines, enforcement actions, and policy issues affecting the pharmaceutical/biotech industry as it pertains to labeling and promotion.
• Represent Regulatory Affairs as a reviewer on medical review committee providing regulatory input on materials that include clinical trial recruitment efforts and field medical resources.
• Provide regulatory review on publications and own responsibility for ensuring compliance with regulatory agencies’ requirements.
• Provide strategic regulatory advice for labeling, taking into consideration marketing use post-approval.
• Interpret and communicate regulatory perspective on promotional and non-promotional activities and risks to all stakeholders and management.
• Coordinate regulatory training on regulatory issues pertaining to advertisement and promotion activities.

Benefits

• Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)
• Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration
• 401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance
• Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities
• Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

What This Job Offers

• Job Type: Full-time
• Career Level: Director