Regulatory Strategy Lead, US Promotions

Biogen; Cambridge (MA); On-site; USD 152,000 - 209,000; Full time

Benefits offered by this job

Medical, Dental, Vision & Life ins.

Fitness & Wellness programs

Paid vacation & holidays

401(k) with match

Tuition reimbursement

Job summary

Biogen is seeking an Associate Director to provide regulatory strategic advice for U.S. communications including disease education, promotional materials, and medical communications.

The role also reviews global materials to ensure competitiveness and compliance with FDA regulations, PhRMA guidelines, and Biogen policies. You will partner with cross-functional teams to deliver compliant, impactful communications while supporting Biogen business objectives.

Qualifications

• Minimum of 4–5 years of regulatory promotional review experience.
• Ability to analyze and communicate risk across interdisciplinary teams.
• Experience ensuring promotional materials comply with FDA regulations and PhRMA guidelines.

Responsibilities

• Provide regulatory input on branded and unbranded materials and education communications.
• Advise on promotional claims implications for late-stage development plans.
• Serve as primary contact with OPDP for designated products.
• Ensure materials align with FDA labeling and 2253 submission requirements.
• Develop relationships with Commercial, Medical, Legal, Compliance, and Labeling teams.

Skills

Regulatory promotional review

Risk assessment and mitigation

Communication (verbal & written)

Deadline driven / detail oriented

Negotiation & interpersonal skills

OPDP liaison

Cross-functional collaboration

Regulatory strategy advice

Education

Bachelor’s degree; advanced degree preferred

Job description

Biogen is seeking an Associate Director to provide regulatory strategic advice for U.S. communications including disease education, promotional materials, and medical communications.

The role also reviews global materials to ensure competitiveness and compliance with FDA regulations, PhRMA guidelines, and Biogen policies. You will partner with cross-functional teams to deliver compliant, impactful communications while supporting Biogen business objectives.