Manager/Sr.
Manager, Regulatory Affairs Strategy
Agios is a biopharmaceutical company focused on providing medicines for some of the world’s most challenging diseases.
We’re committed to applying our scientific leadership in cellular metabolism to transform the lives of patients with genetically defined diseases (GDD), encompassing both rare and more common diseases, and mining the extensive potential in the PK platform.
We are leading the way in advancing PKR activation for hemolytic anemias, including pyruvate kinase (PK) deficiency, thalassemia and sickle cell disease, and have demonstrated a strong commitment to these patient communities.
We continue to foster a productive research engine that yields new insights and potential therapeutic approaches.
We’re a company that cares about our work, each other, and the people who are counting on us the most.
We’re inspired to think big and welcome the different perspectives and backgrounds needed to deliver extraordinary results.
We’re driven to be our best selves, together, so we can reach for the Other Side of Possible.
Agios Pharmaceuticals is searching for a Manager/ Sr.
Manager of Regulatory Affairs Strategy to join our growing Regulatory team.
This individual will be responsible for guiding and executing upon regulatory strategy of compliant, high quality, nonclinical and clinical submissions and interactions in support of early development, registration and life cycle management activities.
This includes supporting regulatory activities to enable clinical development plans and studies, working cross-functionally across the organization.
Key Responsibilities
- Acts as regulatory representative on early and late phase clinical studies, ensuring compliant execution of trials
- Prepares and coordinates regulatory submissions (ie clinical trial applications, formal meeting documentation, life-cycle management submissions, etc.); supports preparations and submission of INDs and marketing applications, as applicable
- Supports and organizes preparations for Health Authoring meetings and teleconferences.
- 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
- Guides and executes regulatory strategy for long-term development planning, including the potential to accommodate expedited development needs
- Collaborates effectively with cross-functional teams and contract research organizations, clearly defining regulatory expectations
- Provides insight and guidance on the implementation of current regulations and assesses regulatory risk based on precedence
- Ensure adherence to current regulations associated with regulatory activities
Minimum Requirements
- Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred
- Manager: Must have minimum of 5 years in Regulatory affairs strategy
- Sr.
Manager: Must have minimum of 7 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