Associate Director, Global Regulatory Affairs, Advertising & Promotion
Genmab, Plainsboro, NJ, United States
Overview
At Genmab, we are dedicated to building extra[not]ordinary® futures by developing antibody products and groundbreaking medicines that change lives in cancer treatment and serious diseases. We strive to create a global workplace where individuals\u2019 unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. Does this inspire you and feel like a fit? Then we would love to have you join us! Role
Associate Director, Global Regulatory Affairs, Advertising & Promotion Compliance
is responsible for ensuring that all promotional materials and activities comply with applicable laws, regulations, and guidelines in the US and other markets. The role involves reviewing promotional materials and providing strategic guidance to commercial teams. Work arrangement
This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Work can be taken in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60‑day period and is 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. Minimum of 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 is strongly preferred. Strong leadership, communication, and interpersonal skills. Ability to work collaboratively and influence cross-functional teams. Ability to manage multiple projects and prioritize competing deadlines. Ability to think strategically and creatively to solve complex regulatory challenges. Compensation and Benefits
For US based candidates, the proposed salary band is $174,320.00 261,480.00. The actual salary offer will consider skills, qualifications, experience, and location. Some positions are eligible for discretionary bonuses and long-term incentives. What You Get When You Join Genmab
Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan with 100% match on the first 6% of contributions Health benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary plans: Critical illness, accident, and hospital indemnity insurance Paid time off: Vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support resources: Child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You
You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for better work-life balance. Offices are open, community-based spaces that connect employees while being immersed in our laboratories. Whether you're in the office or working remotely, we thrive on connecting with each other to innovate. About Genmab
Genmab is an international biotechnology company focused on improving lives through innovative antibody therapeutics. Its team has developed next-generation antibody technology platforms and a proprietary pipeline. Genmab is committed to transforming the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with an international presence across North America, Europe and Asia Pacific. For more information, visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. See our privacy policy and Job Applicant Privacy Notice for handling your data in connection with your application. For NL-based roles, note about fixed-term contracts and renewal may apply.
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At Genmab, we are dedicated to building extra[not]ordinary® futures by developing antibody products and groundbreaking medicines that change lives in cancer treatment and serious diseases. We strive to create a global workplace where individuals\u2019 unique contributions are valued and drive innovative solutions to meet the needs of our patients, care partners, families and employees. Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. Does this inspire you and feel like a fit? Then we would love to have you join us! Role
Associate Director, Global Regulatory Affairs, Advertising & Promotion Compliance
is responsible for ensuring that all promotional materials and activities comply with applicable laws, regulations, and guidelines in the US and other markets. The role involves reviewing promotional materials and providing strategic guidance to commercial teams. Work arrangement
This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Work can be taken in increments of single days or multiple consecutive days, provided it does not exceed 40% within a 60‑day period and is 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. Minimum of 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 is strongly preferred. Strong leadership, communication, and interpersonal skills. Ability to work collaboratively and influence cross-functional teams. Ability to manage multiple projects and prioritize competing deadlines. Ability to think strategically and creatively to solve complex regulatory challenges. Compensation and Benefits
For US based candidates, the proposed salary band is $174,320.00 261,480.00. The actual salary offer will consider skills, qualifications, experience, and location. Some positions are eligible for discretionary bonuses and long-term incentives. What You Get When You Join Genmab
Within the first year, regular full-time U.S. employees are eligible for: 401(k) Plan with 100% match on the first 6% of contributions Health benefits: Two medical plan options (including HDHP with HSA), dental, and vision insurance Voluntary plans: Critical illness, accident, and hospital indemnity insurance Paid time off: Vacation, sick leave, holidays, and 12 weeks of discretionary paid parental leave Support resources: Child and adult backup care, family support programs, financial wellness tools, and emotional well-being support Additional perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses About You
You are genuinely passionate about our purpose You bring precision and excellence to all that you do You believe in our rooted-in-science approach to problem-solving You are a generous collaborator who can work in teams with a broad spectrum of backgrounds You take pride in enabling the best work of others on the team You can grapple with the unknown and be innovative You have experience working in a fast-growing, dynamic company (or a strong desire to) You work hard and are not afraid to have a little fun while you do so Locations
Genmab maximizes the efficiency of an agile working environment, when possible, for better work-life balance. Offices are open, community-based spaces that connect employees while being immersed in our laboratories. Whether you're in the office or working remotely, we thrive on connecting with each other to innovate. About Genmab
Genmab is an international biotechnology company focused on improving lives through innovative antibody therapeutics. Its team has developed next-generation antibody technology platforms and a proprietary pipeline. Genmab is committed to transforming the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO) antibody medicines. Established in 1999, Genmab is headquartered in Copenhagen, Denmark, with an international presence across North America, Europe and Asia Pacific. For more information, visit Genmab.com and follow us on LinkedIn and X. Genmab is committed to protecting your personal data and privacy. See our privacy policy and Job Applicant Privacy Notice for handling your data in connection with your application. For NL-based roles, note about fixed-term contracts and renewal may apply.
#J-18808-Ljbffr