Regulatory Affairs Manager
Location: Somerville, Massachusetts, 02143, United States
Finch Therapeutics is a clinical-stage microbiome therapeutics company leveraging its Human-First Discovery platform to develop a novel class of orally administered biological drugs.
With the capabilities to develop both complete and targeted microbiome therapeutics, Finch is advancing a rich pipeline of candidates designed to address a wide range of unmet medical needs. Finch’s lead candidate, CP101, is in late-stage clinical development for recurrent C. difficile infection (CDI). In June 2020, Finch announced that CP101 met its primary efficacy endpoint in PRISM3, the first of two pivotal trials to support the development of CP101 for the prevention of recurrent CDI. Finch is also developing CP101 for chronic hepatitis B, and FIN-211 for autism spectrum disorder. In partnership with Takeda, Finch is advancing FIN-524 and FIN-525 for ulcerative colitis and Crohn’s disease, respectively.
Finch is seeking a Regulatory Affairs Manager who will assist in developing regulatory strategy and participate on various product development teams. The incumbent will assist in the preparation, writing and submission of regulatory documents such as pre-IND meeting requests, INDs, CTAs and BLAs. This individual will provide regulatory advice and guidance to cross functional product development teams and assist in the development of long-range regulatory plans.
Responsibilities / Duties
- Prepare amendments, annual reports and supplements for submissions to FDA and other health authorities.
- Work closely with Regulatory Director on product development teams, providing advice on CMC submission planning.
- Review and submit change requests to management regarding any changes to regulatory
- Mange the relationship between Finch and our external consulting teams ensuring timely delivery of deadlines on FDA clinical, quality & regulatory compliance
- Ensure that all documents are filed and archived properly in accordance with SOPs and regulatory agency
- Track the committed timeliness and follow up with the internal departments proactively for required documents.
- Provide accurate and timely assessment of change control documents for determination of reporting category.
- In collaboration with the Regulatory Director, provide appropriate regulatory guidance to quality and manufacturing/operations
- Bachelor’s degree required; Advanced degree preferred
- 5-8 years of experience in Regulatory Affairs, Quality or Manufacturing is required
- Pharma and/or Biotech experience is required
- Experience preparing pre-IND and IND documentation is required
- Regulatory project management experience is highly desired
- Experience working with CBER and supporting the development of novel therapeutic categories is highly desired
- Experience preparing BLA documentation is highly desired
- Time management, organization and planning skills, multi-tasking and prioritization skills in a fast- paced environment are required
- Excellent written and verbal communication skills and interpersonal skills
- Ability to work in a matrix environment with cross-functional teams
More About Finch
Here at Finch, we strive to create the best work environment and experience for you through our formal benefits programs and fringe perks. Together, we hope that we’ll create a fun & supportive environment in and out of the workplace as we strive to create a new class of therapeutics together to help patients.
- Our formal benefits include medical, dental, and vision coverage through Harvard Pilgrim in addition to life insurance and long-term & short-term disability policies. We offer discretionary and flexible paid time off policies. Should you choose to start or grow your family while working at Finch, we aspire to lead our peers by offering several months of paid parental leave. We also offer a generous non-discretionary 401K contribution to help teammates save for life beyond Finch in the future and other savings and investment opportunities.
- We also try to keep the workplace an inspiring and motivating place to work with our fringe perks. Our facilities in Somerville, MA include an in-office gym with a shower and towel service, fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap, and highly subsidized meals through LeanBox. We sponsor ride-sharing to and from the office from preset locations around Boston, Cambridge, and Somerville. We are always evaluating our fringe perks and hope to grow them alongside our team.
*Only facility-dependent employees are working on-site in Somerville until further notice.
Equal Opportunity Employer
We are committed to recruiting, developing, and retaining the most talented people from a diverse candidate pool. All aspects of employment including the decision to hire or promote, will be based on aptitude, performance, and business need. We do not discriminate on the basis of race, color, religion, sex, national origin, age, physical or mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, or any other legally protected status. Finch will make reasonable accommodations for qualified individuals with disabilities, in accordance with applicable law.