Director Regulatory Affairs

Company: Riot Games
Location: Somerville
Posted on: February 26, 2021

Job Description:

Location: Somerville, Massachusetts, 02143, United States Full-time About Finch Finch is a clinical-stage company developing novel microbiome drugs to serve patients with serious unmet medical needs. Our machine learning-based platform mines molecular data collected from human interventional studies to identify the microbial communities driving positive patient outcomes in different disease areas. By developing drugs from microbial communities that have already demonstrated therapeutic effects in humans, we are pioneering a new approach to drug discovery and rapidly transforming the promise of the microbiome into a reality for patients. Our lead therapeutic candidate, CP101, is initially targeting the prevention of recurrent C. difficile infection (CDI). CP101 recently met its primary endpoint in a large placebo-controlled trial in recurrent CDI, providing the first positive pivotal data for an oral microbiome drug. We also have programs targeting the treatment of chronic hepatitis B, children with autism and serious GI symptoms, as well as two programs partnered with Takeda Pharmaceuticals targeting inflammatory bowel disease. Position Summary The Director Regulatory Affairs is responsible for 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 strategic regulatory plans. The incumbent implements these plans through coordination, authorship and development of drug applications and submissions, and through regulatory agency interactions. This position reports to the Senior Vice President of Regulatory Affairs and Quality. Responsibilities / Duties

• Responsible for day-to-day engagement with project teams to support the regulatory aspects of all clinical development programs.
• Represents the Regulatory Affairs function on program development teams.
• Oversees 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.
• Oversees and manages regulatory affairs manager(s) and specialist(s). Qualifications
  • Bachelor's degree required; advanced degree preferred
  • 10+ years of experience in Regulatory Affairs experience
  • Pharma and/or Biotech industry experience
  • Working knowledge of FDA Submission Readiness Standards
  • Experience preparing 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 Blue Cross Blue Shield 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 expand 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. *Though only facility-dependent employees are currently working onsite in Somerville, Ma, we all plan to return to the office when it's safe to do so. 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.

Keywords: Riot Games, Somerville , Director Regulatory Affairs, Executive , Somerville, Massachusetts