Director/Sr. Director Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory

The impact you will make

Agios Pharmaceuticals is searching for a dynamic Director/Sr Director, Regulatory Labeling Strategy, Advertising, and Promotion to provide expert, strategic regulatory guidance and oversight for all labeling activities and promotional and non-promotional communications to ensure compliance with applicable regulations, including FDA requirements.

What you will do

• Provide global regulatory labeling expertise and ensure adherence to global regulations in support of the development, review, and approval of labeling documents.
• Manage the creation and/or maintenance of global labeling strategy and documents (e.g. CCDS, regional product information, and patient leaflets).
• Collaborate closely with Commercial, Clinical, Legal, and Medical, as well as other cross-functional stakeholders within research and development, to shape compliant messaging strategies and effective labeling documents
• Lead regulatory strategy for advertising and promotional materials across all stages (pre-approval, launch, and lifecycle) by serving on the Agios Review Committee (ARC) as the Regulatory Reviewer responsible for the review and approval of promotional and non-promotional materials across the Agios portfolio
• Serve as the internal subject matter expert on FDA advertising and promotion regulations, including OPDP expectations and evolving enforcement trends
• Ensure timely and accurate FDA 2253 submissions of US promotional materials.
• Interface with regulatory authorities (e.g., OPDP) as needed, including managing inquiries or enforcement responses
• Provide risk-based guidance that balances compliance with business impact and speed
• Ensure all materials (HCP, patient, digital, payer, investor-facing where applicable) meet regulatory requirements
• Guide teams on appropriate claim substantiation, fair balance, and risk disclosure
• Regularly assess labeling updates to determine their impact on previously approved materials and identify when revisions are required, ensuring changes are reflected in current promotional and advertising materials.
• Influence brand planning, campaign development, and launch readiness
• Act as a trusted advisor to senior leadership on promotional risk and opportunity
• Develop and maintain internal policies, SOPs, and guidance related to labeling and promotional practices
• Drive continuous improvement of review processes to enhance speed, clarity, and effectiveness
• Implement scalable systems appropriate for a growing organization
• Lead /oversee training programs for cross-functional teams on labeling regulatory requirements and best practices
• Foster a culture of compliant innovation and accountability

What you bring

• Bachelor’s degree required; advanced degree (PhD, PharmD, JD, or MS) preferred
• Director:- 10+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• 7+ years experience developing regulatory labeling documents (CCDS, local labels, patient leaflets).
• 7+ years experience in Advertising & Promotion / OPDP compliance
• Senior Director:- 15+ years of experience in Regulatory Affairs within the biopharmaceutical industry
• 12+ years experience developing regulatory labeling documents (CCDS, local labels, patient leaflets).
• 12+ years experience in Advertising & Promotion / OPDP compliance
• Demonstrated experience leading Medical, Legal and Regulatory review processes
• Strong knowledge of FDA regulations, guidance, and enforcement trends related to promotion
• Proven ability to operate both strategically and tactically
• Strong track record of cross-functional influence, external engagement, and operating effectively in a matrixed environment with cross-functional teams
• Experience supporting late-stage assets and/or product launches preferred