Associate Director, Advertising and Promotion – Global Regulatory Affairs

Biogen

Associate Director guiding FDA-compliant advertising and promotion for Biogen, a neuroscience biotechnology company. Advising teams on promotional materials, disease communications, and regulatory risk for neurological medicines.

Posted 8/5/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesSenior💰 $152,000 - $209,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in regulatory strategy and compliance, particularly in promotional review and FDA regulations. Capable of analyzing risk and effectively communicating with interdisciplinary teams to ensure alignment with business goals.

Highest-signal resume keywords

Regulatory Promotional Review ExperienceFDA Regulations ComplianceRisk Assessment and MitigationInterpersonal and Negotiation SkillsStrategic Input on Promotional Claims

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory StrategyRisk AssessmentPromotional Claims AnalysisFDA Submission RequirementsData InterpretationRegulatory CompliancePromotional Material ReviewClinical Development PlansDisease Information AnalysisStrategic Advice for Advisory Comments

Soft Skills

Detail OrientedDeadline OrientedOrganizational SkillsCommunication SkillsTeam Collaboration

Industry Keywords

Office of Prescription Drug PromotionCommercial OperationsMedical CommunicationsSales Training MaterialsLabeling ComplianceInterdisciplinary TeamsDynamic Environment AdaptabilityConsensus BuildingPartnership DevelopmentPromotional Materials

About the role

Key responsibilities & impact

Provide regulatory strategic input, risk assessment, and mitigation strategies to global and U.S. internal teams on branded and unbranded concepts, promotional materials, disease awareness communications, medical communications, and sales training/education materials
Provide strategic input on promotional claims implications for late-stage clinical development plans
Provide creative and solution-oriented feedback to meet business goals
Serve as the primary point of contact with the Office of Prescription Drug Promotion (OPDP) for designated products
Provide strategic advice for Advisory Comments submissions
Ensure promotional materials are consistent with FDA-approved labeling and compliant with FDA regulations and 2253 submission requirements
Develop and maintain relationships with Commercial, Medical, Legal, Compliance, Regulatory Strategy and Labeling, and Medical/Marketing Operations teams
Work with management and Reg AP team members to ensure communications and feedback are consistent across franchises
Monitor the evolving regulatory landscape and communicate updates to internal stakeholders

Requirements

What you’ll need

BS required; advanced degree preferred
Minimum of 4-5 years of Regulatory promotional review experience
Detail and deadline oriented; well organized
Capability to analyze and assess risk and effectively communicate across interdisciplinary teams
Ability to dissect and interpret complex disease information and product efficacy/safety data
Strong negotiation and interpersonal skills to influence others and build team collaboration, consensus and partnerships
Ability to adapt to dynamic environment and business needs
Ability to develop and maintain relationships with OPDP
Excellent verbal, written, and presentation skills

Benefits

Comp & perks

Short-term and long-term incentives, including cash bonus and equity incentive opportunities
Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation
Additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation
Opportunities for learning, growth, and expanding skills