Director, Regulatory Affairs at Acceleron Pharma
Cambridge, MA, US
Who are we?
Acceleron is a 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 program with ACE-083, a locally-acting Myostatin+ agent in Phase 2 development in facioscapulohumeral muscular dystrophy and Charcot-Marie-Tooth disease and is conducting a Phase 2 pulmonary program with sotatercept in pulmonary arterial hypertension.
What’s in it for you?
With key regulatory milestones approaching for its lead product candidate, and other pipeline assets advancing in the clinic, Acceleron is entering one of the most exciting periods in its history. This will be a time of dynamic growth, requiring timely, strategic decision making to inform, motivate, and energize internal and external stakeholders.
Reporting to the Senior Vice President, Regulatory Affairs and Quality, you will lead the Regulatory strategy and initiatives for our pulmonary therapeutic area. By joining our growing and dynamic regulatory affairs team, you’ll be responsible for the preparation and maintenance of INDs and clinical trial applications that are compliant with US, foreign regulatory requirements, and company standards. You will provide regulatory guidance and oversight and improve internal standards and systems.
What will you be doing?
What are we looking for?
- Act as the primary regulatory representative on and provide strategic regulatory guidance to project teams and sub-teams
- Lead the planning and preparation of global regulatory global submissions (eg, INDs, CTAs, IND safety reports, meeting requests)
- Establish and manage regulatory timelines
- Serve as the liaison between the company and regulatory agencies for assigned projects
- Prepare meeting requests and briefing documents; assure team is ready for meetings/teleconferences with regulatory agencies
- Prepare regulatory development plans for assigned projects
- Develop and maintain regulatory knowledge of US, EU and ROW regulations
- Coordinate and prepare responses in response to Regulatory Agency requests
- Perform literature searches, prepare special reports and assemble documentation to support project teams
- Interface with CMC, nonclinical research and clinical research personnel and help keep them apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company
- Maintain active INDs/CTAs (amendments and annual reports)
- Assist in the development and maintenance of departmental processes, policies, SOPs and associated documents
- Participate in initiatives aimed at improving internal departmental standards and systems
- Minimum of 8 years’ experience in a biotech and/or pharmaceutical environment, including 4-5 years in Regulatory Affairs
- Minimum requirement of a Bachelor’s Degree in a scientific discipline or equivalent
- Experience working with biologics
- Experience in multiple therapeutic areas preferred
- Experience in orphan drug development a plus
- You must be a team player that can handle multiple tasks simultaneously in a fast-paced 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
- Experience with bio-pharmaceuticals is desirable
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.