Associate Director/Director, Regulatory Affairs- CMC
Regulatory Cambridge, MA
Who are we? Acceleron is a Cambridge-based, clinical-stage biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. The Company’s leadership in the understanding of TGF-beta biology and protein engineering generates innovative compounds that engage the body’s ability to regulate cellular growth and repair. Acceleron focuses its research and development efforts in hematologic, neuromuscular, and pulmonary diseases. In hematology, the Company and its global collaboration partner, Celgene, are developing luspatercept for the treatment of chronic anemia in myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. Acceleron is also advancing its neuromuscular franchisewith two distinct Myostatin+ agents, ACE-083 and ACE-2494, and a pulmonary program with a Phase 2 trial of sotatercept planned in pulmonary arterial hypertension.
What’s in it for you?
This opportunity will allow you to be a part of our talented and team-oriented Regulatory group during an exciting time of growth at Acceleron. You will lead the CMC regulatory strategy and processes for assigned programs to significantly contribute in driving the development of our assets forward.
What will you be doing?
- Acting as the primary CMC regulatory representative on selected programs to develop CMC regulatory strategies, submissions and compliance activities
- Managing CMC regulatory activities and timelines
- Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements
- Leading the planning and preparation of the CMC sections of global regulatory submissions
- Collaborating with the greater CMC teams to provide regulatory guidance
- Developing and maintaining regulatory knowledge of US, EU and ROW regulations
- Performing literature searches, preparing special reports and assembling documentation tosupport project teams
- Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents
- Participating in initiatives aimed at improving internal departmental standards and systems
What are we looking for?
- Minimum of 8 years of experience in a biotech and/or pharmaceutical environment, including 4-5 years of Regulatory CMC experience
- Minimum requirement of a Bachelor’s Degree in a scientific discipline or equivalent
- Experience with biologics program from development through registration
- Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.)
- Experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.)
- Knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
- You must be a team player that can handle multiple tasks simultaneously in a fast growing company
- Possess outstanding verbal and written communication skills
- Requires a highly motivated, resourceful, creative individual who can set goals, shift priorities, work independently and collaborate effectively with project teams
- Excellent organizational skills and attention to detail