Associate Director, Regulatory Strategy

Full Time On-Site/Hybrid Regulatory Affairs Director Regulatory Strategy Apply for this Job 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 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 an Associate Director of Regulatory Strategy to join our growing Regulatory team. The Associate Director of Regulatory Affairs Strategy will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization. This individual will be responsible for preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support early development, registration, and life cycle management.

What you will do:

• Develop and execute, or oversee 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.
• Plan, lead, develop, and review regulatory submissions, such as clinical trial and marketing applications, life-cycle management submissions.
• Plan and lead health authority interactions and develop or contribute to the development and review of associated documents.
• Manage and mentor individuals within the regulatory affairs team, providing guidance and support as needed.
• 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.
• 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.