Oversee a team of US promotional reviewers, ensuring timely and collaborative review of promotional materials for marketed and pipeline assets.
Provide strategic guidance on claims, fair balance, risk communication, and product differentiation throughout development and commercialization.
Serve as a trusted advisor on regulatory risk, opportunity assessment, and decision-making related to product communication.
Stay informed on FDA regulations, advisory comments, and compliance initiatives, educating cross-functional partners.
Collaborate with Commercial, Medical Affairs, Legal, Market Access to enable compliant product communications to meet/exceed business objectives with compliant product/pipeline communications.
Adapt policies and capabilities to new channels and technologies, considering digital and social media, omnichannel engagement, and AI-enabled content generation.
Oversee a Labeling team responsible for activities across the product lifecycle, including target label profile development, indication expansions, core data sheets, and safety updates.
Partner with Global Regulatory Affairs to develop target labeling profiles and ensure development plans support labeling objectives.
Support development of internal policies, SOPs, and training programs related to labeling, advertising, and promotion.
Build, develop, and mentor a high-performing team of regulatory professionals across labeling and advertising/promotion.
Foster a culture of ownership, accountability, collaboration, and scientific rigor.
Ensure scalable processes and capabilities that support portfolio growth, including new launches and acquisitions.
Be accountable for budget and resource planning for the ALP function.
At least 15 years of progressive regulatory experience within the pharmaceutical or biotechnology industry.
Demonstrated leadership experience overseeing advertising and promotion review for marketed products.
Significant hands-on experience with product labeling development.
Experience supporting early-stage pipeline programs through launch and post-approval lifecycle management.
Prior people leadership and matrixed team management experience required.
Preferred Skills
Expert command of FDA OPDP requirements, enforcement trends, guidance, and case law.
Mastery of global labeling frameworks including FDA (PLR, CDS, SPL, USPI), EMA/SmPC, and regional variations (PMDA, MHRA, Swissmedic, TGA, etc.).
Strong working knowledge of claims substantiation standards, fair balance and risk communication, comparative and disease awareness advertising.
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Job Level: Management
Additional Information
The base compensation range for this role is: $300,000.00-$424,000.00
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.
Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.
In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial,
Benefits
Health insuranceEquity / stock optionsPerformance bonus
Additional Information
About This Role
As the Head of Advertising, Labeling, and Promotion (ALP), you will play a pivotal role in shaping and executing the regulatory strategy for product labeling, promotional review, and advertising activities across a diverse portfolio of marketed products and pipeline assets. You will ensure that labeling and promotional materials are scientifically accurate, compliant with FDA regulations, and strategically aligned with the company's objectives throughout the product lifecycle. Reporting directly to the Senior Vice President of Global Regulatory Affairs, you will be an integral member of the GRA Leadership Team, collaborating closely with Commercial, Legal, Medical Affairs, and Regulatory Strategy to enable compliant product launches and sustained lifecycle value. This role is vital for achieving marketplace success and supporting the overall business structure through effective and compliant product communication.
Biogen · Cambridge, MA