Associate Director, Global Regulatory Affairs, Advertising & Promotion
Genmab
12 hours ago
Remote friendly (Princeton, NJ)
United States
Marketing
Associate Director, Global Regulatory Affairs, Advertising & Promotion Compliance
Work arrangement:
- Flexibility to work away from the office for 20%–40% of a typical schedule (increments of single or consecutive days), not exceeding 40% within a 60-day period, and approved by the hiring manager.
Responsibilities:
- Provide regulatory guidance and direction to the cross-functional Medical, Regulatory and Legal (MeRL) Committee.
- Ensure timely and accurate submission of promotional materials to the FDA OPDP.
- Monitor and assess the impact of new or changing regulations, guidances, and enforcement actions on promotional activities.
- Provide training and education to internal and external stakeholders on regulatory requirements and best practices for advertising and promotion.
- Establish and maintain effective relationships with regulatory agencies, alliance partners, and industry associations.
Qualifications:
- Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred.
- 6–8 years of experience in Regulatory Advertising and Promotion Compliance.
- Expert knowledge of US laws, regulations, and guidances related to pharmaceutical advertising and promotion.
- Experience with accelerated approval products (strongly preferred).
Skills:
- Strong leadership, communication, and interpersonal skills.
- Ability to collaborate and influence cross-functional teams.
- Ability to manage multiple projects, prioritize competing deadlines, and think strategically/creatively to solve complex regulatory challenges.
Benefits (U.S. regular full-time employees, within first year):
- 401(k) with 100% match on the first 6% of contributions; medical/dental/vision options; voluntary plans (critical illness, accident, hospital indemnity); paid vacation/sick leave/holidays and 12 weeks discretionary paid parental leave; child/adult backup care and family support programs; financial wellness tools and emotional well-being support; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.
Work arrangement:
- Flexibility to work away from the office for 20%–40% of a typical schedule (increments of single or consecutive days), not exceeding 40% within a 60-day period, and approved by the hiring manager.
Responsibilities:
- Provide regulatory guidance and direction to the cross-functional Medical, Regulatory and Legal (MeRL) Committee.
- Ensure timely and accurate submission of promotional materials to the FDA OPDP.
- Monitor and assess the impact of new or changing regulations, guidances, and enforcement actions on promotional activities.
- Provide training and education to internal and external stakeholders on regulatory requirements and best practices for advertising and promotion.
- Establish and maintain effective relationships with regulatory agencies, alliance partners, and industry associations.
Qualifications:
- Bachelor’s degree in life sciences, pharmacy, or related field; advanced degree preferred.
- 6–8 years of experience in Regulatory Advertising and Promotion Compliance.
- Expert knowledge of US laws, regulations, and guidances related to pharmaceutical advertising and promotion.
- Experience with accelerated approval products (strongly preferred).
Skills:
- Strong leadership, communication, and interpersonal skills.
- Ability to collaborate and influence cross-functional teams.
- Ability to manage multiple projects, prioritize competing deadlines, and think strategically/creatively to solve complex regulatory challenges.
Benefits (U.S. regular full-time employees, within first year):
- 401(k) with 100% match on the first 6% of contributions; medical/dental/vision options; voluntary plans (critical illness, accident, hospital indemnity); paid vacation/sick leave/holidays and 12 weeks discretionary paid parental leave; child/adult backup care and family support programs; financial wellness tools and emotional well-being support; commuter benefits, tuition reimbursement, and Lifestyle Spending Account.