What are the responsibilities and job description for the Sr. Manager, Regulatory Operations position at Agios Pharmaceuticals?
Senior Manager, Regulatory Operations
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 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 dynamic Senior Manager of Regulatory Operations to join our growing Regulatory Affairs team. We want someone who cares about this important work, and who's driven to connect to our mission of helping these patient communities. The Senior Manager of Regulatory Operations is responsible for submission management activities and regulatory information management for global applications. This role ensures compliance with evolving global health authority / ICH regulations and guidelines for electronic submission. Additional opportunity to support our Agios Review Committee in the coordination of the review of promotional and non-promotional materials.
What you will do :
- Partner with Regulatory Affairs Lead(s) to plan and prepare global health authority submissions.
- Manage submission deliverables, according to timelines, within Veeva RIM; ensure accuracy (advanced editing / formatting support of submission documents and document-level publishing).
- Oversee timely transmittal of submissions to global health authorities, coordinating activities with external publishing vendor.
- Archive health authority communications and maintain health authority question and commitment records within Veeva RIM.
- Plan, prepare and transmit OPDP submissions as needed.
- Support and partner with Regulatory and cross-functional team members to ensure compliance with and provide guidance on submission standards and processes. Ensure strong communication to identify and address challenges and opportunities for efficiencies.
- Lead and contribute to Regulatory Operations initiatives (process changes and system implementations / enhancements); recommend and help implement associated process improvements.
- Support Agios Review Committee (ARC) in coordination activities (review of promotional and non-promotional materials) as needed.
What you bring :
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 :
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.
