Sr. Manager/Associate Director, Regulatory Affairs Strategy - Labeling

Sr. Manager/Associate Director, Regulatory Affairs Strategy – Labeling

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare disease – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.   
 

Agios Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy - Labeling to join our growing Regulatory team. The Senior Manager/ Associate Director of Regulatory Affairs Strategy will be responsible for working cross-functionally across the organization to manage and guide the development and maintenance of global labeling (e.g. CCDS, regional product information, and patient leaflets), to contribute to and execute upon regulatory strategies to support clinical development plans, and to prepare and coordinate compliant, high quality, nonclinical and clinical global regulatory submissions across early development, registration, and life cycle management.

What you will do:

• Manage the creation and/or maintenance of global labeling strategy and documents (e.g. CCDS, regional product information, and patient leaflets) 
• With appropriate supervision and guidance, lead cross-functional labeling teams, facilitating discussions on labeling strategies and content, and ensuring cross-functional collaboration and alignment.
• Contribute to and execute global regulatory labeling strategy for long-term planning, including the potential to accommodate expedited development needs
• Work within cross-functional teams to provide global regulatory labeling and strategy expertise in support of the development, review, and approval of strategies and documents intended to ultimately support labeling or marketing authorizations
• Support preparations for marketing applications or other regulatory submissions
• Support preparations for health authority interactions, as relevant, and develop or contribute to the development and review of associated documents
• Engage with Regulatory Authorities on labeling related matters, as needed
• Ensure adherence to current regulations associated with regulatory labeling and strategy activities

What you will bring:

• Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred
• Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy or labeling 
• Senior Manager: Must have minimum of 6 years pharmaceutical industry with 5 years in Regulatory affairs strategy or labeling 
• Must have experience and understanding of regulatory product information labeling (e.g. Company Core Data Sheet, USPI, SmPC); Prior experience in leading labeling activities is preferred
• Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
• Excellent organizational and communication skills, both written and verbal
• Ability to work independently as well as part of a team environment
• Positive attitude, energetic and proactive
• Proven ability to manage multiple projects, identify and resolve regulatory issues
• Strong interpersonal skills and the ability to effectively work with others

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.
• Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
• 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.