Senior Manager/Associate Director, Regulatory Affairs Strategy

Sr. Manager/Associate Director, Regulatory Affairs Strategy

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 genetically defined diseases – 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.

The impact you will make:

Agios Pharmaceuticals is searching for a Senior Manager/Associate Director of Regulatory Affairs Strategy 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 and guide the development and maintenance of global labeling (e.g. CCDS, regional product information, and patient leaflets)
• Contribute to and execute global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs
• Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations
• Prepare and coordinate regulatory submissions, such as clinical trial applications, INDs, and life-cycle management submissions; support preparations for marketing applications
• Support preparations for health authority interactions and develop or contribute to the development and review of associated documents
• Engage with Regulatory Authorities on project related matters, as needed
• Ensure adherence to current regulations associated with regulatory 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 Specific – Field/Remote: This is a remote based field position. Employees in field roles must reside within their designated territory. Regular conversations with manager are encouraged to ensure alignment on in-person presence/expectations. Travel may be required commensurate to the above job description and/or to attend team meetings and other company events.

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.