Associate Director Advertising and Promotion, Global Regulatory Affairs
Biogen
August 13, 2026
Remote friendly (Cambridge, MA)
United States
Marketing
Responsibilities
- Provide regulatory strategic input, risk assessment, and mitigation strategies to global and U.S. internal teams on branded/unbranded concepts, promotional materials, disease awareness, medical communications, and sales training/education materials.
- Provide strategic input on promotional claims implications for late-stage clinical development plans.
- Provide creative, solution-oriented feedback to meet business goals.
- Serve as primary point of contact with the Office of Prescription Drug Promotion (OPDP) for designated product(s).
- Provide strategic advice for Advisory Comments submissions.
- Ensure promotional materials are consistent with FDA-approved labeling, comply with applicable FDA regulations, and are completed per 2253 submission requirements.
- Develop and maintain strong relationships across Commercial, Medical, Legal, Compliance, Regulatory Strategy/Labeling, and Medical/Marketing Operations.
- Work with management and Regulatory Affairs Advertising & Promotional (Reg AP) team members to ensure consistent communications across franchises.
- Assist Regulatory Ad Promo in monitoring evolving regulatory landscape and communicating updates.
Qualifications / Required Skills
- BS required; advanced degree preferred.
- 4-5+ years of Regulatory promotional review.
- Detail- and deadline-oriented; well organized.
- Ability to analyze/assess risk and communicate across interdisciplinary teams.
- Ability to interpret complex disease information and product efficacy/safety data.
- Strong negotiation and interpersonal skills to build collaboration and consensus.
- Adaptable to dynamic business needs.
- Ability to develop/maintain relationships with OPDP.
- Excellent verbal, written, and presentation skills.
Benefits / Compensation (as stated)
- Base compensation range: $152,000-$209,000; eligibility for short- and long-term incentives.
- Medical, dental, vision, life; fitness/wellness; short- and long-term disability; paid vacation and holidays; sick time; paid maternity/parental leave; 401(k) with match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.
- Provide regulatory strategic input, risk assessment, and mitigation strategies to global and U.S. internal teams on branded/unbranded concepts, promotional materials, disease awareness, medical communications, and sales training/education materials.
- Provide strategic input on promotional claims implications for late-stage clinical development plans.
- Provide creative, solution-oriented feedback to meet business goals.
- Serve as primary point of contact with the Office of Prescription Drug Promotion (OPDP) for designated product(s).
- Provide strategic advice for Advisory Comments submissions.
- Ensure promotional materials are consistent with FDA-approved labeling, comply with applicable FDA regulations, and are completed per 2253 submission requirements.
- Develop and maintain strong relationships across Commercial, Medical, Legal, Compliance, Regulatory Strategy/Labeling, and Medical/Marketing Operations.
- Work with management and Regulatory Affairs Advertising & Promotional (Reg AP) team members to ensure consistent communications across franchises.
- Assist Regulatory Ad Promo in monitoring evolving regulatory landscape and communicating updates.
Qualifications / Required Skills
- BS required; advanced degree preferred.
- 4-5+ years of Regulatory promotional review.
- Detail- and deadline-oriented; well organized.
- Ability to analyze/assess risk and communicate across interdisciplinary teams.
- Ability to interpret complex disease information and product efficacy/safety data.
- Strong negotiation and interpersonal skills to build collaboration and consensus.
- Adaptable to dynamic business needs.
- Ability to develop/maintain relationships with OPDP.
- Excellent verbal, written, and presentation skills.
Benefits / Compensation (as stated)
- Base compensation range: $152,000-$209,000; eligibility for short- and long-term incentives.
- Medical, dental, vision, life; fitness/wellness; short- and long-term disability; paid vacation and holidays; sick time; paid maternity/parental leave; 401(k) with match; stock purchase plan; tuition reimbursement up to $10,000/year; Employee Resource Groups participation.