Forma Therapeutics is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapeutics to transform the lives of patients with rare hematologic diseases and cancers. Our R&D engine combines deep biology insight, chemistry expertise and clinical development capabilities to create drug candidates with differentiated mechanisms of action focused on indications with high unmet need. Our work has generated a broad proprietary portfolio of programs with the potential to provide profound patient benefit. For more information, please visit www.FormaTherapeutics.com or follow us on Twitter @FORMAInc and LinkedIn.
About the Role:
As a member of the Forma Regulatory team, the Regulatory Manager will contribute to the progress of assigned drug candidates. The manager will support program regulatory lead(s) with major filings (INDs, NDAs, MAAs) and work collaboratively with cross functional teams to support development milestones.
The RA Manager will also be responsible for managing CROs responsible for Ex-US clinical trial applications including driving submission strategies and timelines, reviewing and approving submission components, and working within Forma teams to create or obtain required submission documents. The Manager will also take a leadership role in establishing internal regulatory tracking
systems and archiving systems and developing regulatory SOPs. The ideal candidate will be a motivated self-starter who thrives in a fast-paced, small team dynamic environment. The RA Manager will be expected to:
- Compile and manage regulatory submissions for assigned projects
- Responsible for supporting active INDs and CTAs including planning for and coordinating IND maintenance submissions managing CROs responsible for clinical trial applications outside of the US and responding to questions
- Support regulatory lead and contribute to the development and implementation of CMC, nonclinical, and clinical regulatory strategies for projects in all stages of development (pre-IND through commercial) for assigned projects
- Support preparation for Health Authority interactions including preparing meeting requests and briefing books
- Responsible for developing or contributing to the development of project timelines and the planning of regulatory milestones
- Contribute to the continuous improvement of existing department processes and strategies
- Maintain regulatory archives and submission trackers
- Contribute to and Develop regulatory SOPs
- Bachelor’s degree in life sciences or equivalent. Secondary degree (Pharm D, Ph.D.) is preferred.
- At least 2 years’ experience in Regulatory Affairs experience in the biotechnology or pharmaceutical industry preferred.
- Experience in developing and finalizing quality successful regulatory submissions to the FDA.
- Demonstrated working knowledge of systems and technology used for the preparation and review of regulatory submissions.
- Excellent communication, interpersonal, negotiation and project management skills.
- Effective team player with a demonstrated ability to work effectively in a small-team, cross-functional environment.
- Must be detail-oriented with well-developed organizational and analytical skills, accuracy, and reliability.
Headquartered in Watertown, MA, we have all the perks you can find in Cambridge (walkable to
lunch, shopping, etc.) and more perks that you can’t (ample free parking!) Our diverse portfolio and our commitment to patients sets us apart. Our patients are our true north; our pipeline is our road map. Everyone at Forma is a part of the journey. #formafuturewithforma
Learn more here
Job posted: 2020-07-27