Associate Director, Regulatory Affairs
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.
The Associate Director Regulatory Affairs is responsible for assisting the product Regulatory Leads with developing and implementing regulatory strategy and is an active partner in drug development project planning and execution. This position works within cross-functional development project teams and provides expertise in translating clinical and CMC regulatory requirements into practical regulatory submission plans. The incumbent implements these plans through coordination, Regulatory project management, authorship and development of drug applications and submissions, and through regulatory agency and contract research organization interactions.
This position reports to the Chief Regulatory Officer.
Responsibilities / Duties
- Responsible for day-to-day engagement with product Regulatory Leads and/or project teams to support the regulatory aspects of all clinical and/or CMC development programs.
- May represent the Regulatory Affairs function on program development teams or specific subteams.
- Provides Regulatory project management leadership to the preparation of INDs, CTAs, BLAs, amendments and supplements, annual reports, DSURs, and supplements for FDA and other regulatory health authority submissions.
- Reviews and submits change requests to management regarding any changes to regulatory documents.
- Manages the relationship between Finch and our external consulting teams ensuring timely delivery of deadlines on FDA-related clinical, quality & regulatory compliance projects.
- Responsible for managing regulatory activities provided by CROs in non-US global regions.
- Ensures that all documents are filed and archived properly in accordance with SOPs and regulatory agency requirements.
- Tracks committed timelines and follows up with the internal departments proactively for required documents.
- Provides accurate and timely assessment of change control documents for determination of reporting category.
- Provides appropriate regulatory guidance to clinical, research, quality and manufacturing and operations departments in collaboration with the product Regulatory Leads.
- Bachelor’s degree required; advanced degree preferred
- 7+ years of experience in Regulatory Affairs, with specialty in either CMC Regulatory or Clinical Regulatory
- Pharma and/or Biotech industry experience
- Working knowledge of FDA Submission Readiness Standards
- Experience preparing and leading project management activities for pre-IND and IND documentation
- 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
- Ability to maintain a high level of accuracy and attention to detail, while meeting deadlines for assigned projects
- Excellent written and verbal communication skills and interpersonal skills
- Ability to work in a matrix environment with cross-functional teams including a variety of scientific disciplines, bioprocess and manufacturing
- Passion, humility, and excitement for doing whatever it takes to drive research forward
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 (temporarily closed due to COVID), fully stocked kitchen with free snacks, iced coffee & flavored/sparkling waters on tap. 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.