Senior Director, Regulatory Affairs

Director/Sr. Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Who we are: At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture – one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion – because our differences shape how we hire, collaborate, and innovate. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific – it’s deeply personal, grounded in the meaningful connections we have built. To learn more, visit and follow Agios on LinkedIn and X. 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. This individual will be responsible for development of global labeling documents (e.g. CCDS, regional product information, and patient leaflets) and serve on the Agios Review Committee as the Regulatory Reviewer responsible for the review and approval of promotional and non‑promotional materials across the Agios portfolio. This individual will partner cross‑functionally with Legal, Commercial, Corporate Communications, and Medical, as well as other cross‑functional stakeholders within the Research and Development organization, to enable compliant, effective messaging, development of labeling, and promotional and non‑promotional materials to support business objectives while protecting the company’s integrity and reputation. 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. Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening! Work Location: Location Agnostic: Work location for this role is based on employee’s individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending company‑sponsored events/meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description. What we will give you: Deliberate Development. Your professional growth as one of our top priorities. Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best. Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well‑rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website. Competitive and equitable performance‑based compensation. This includes base salary and both short‑ and long‑term incentives that are connected to our business strategy and vary based on individual and company performance. The current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized and the current base salary range for this position at the Senior Director level is expected to be between $229,562 and $344,342 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data‑informed risks to help push the boundaries. Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce. Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked. Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website. #J-18808-Ljbffr