SomervilleRecruiter Since 2001
the smart solution for Somerville jobs

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

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category

Other Executive Jobs

Senior Project Manager (Transportation - Design
Description: Career Opportunities with McMahon Associates A great place to work. Share with friends or Subscribe Current job opportunities are posted here as they become available. Subscribe to our RSS feeds to (more...)
Company: McMahon Associates
Location: Taunton
Posted on: 02/27/2021

Regulatory Affairs Operations Manager
Description: This job is available in 2 locations Job Type Full time Job Id 392227 Posted Date: 02/08/2021 If you are a Colorado resident and this role is a field-based or remote role, you may be eligible to receive (more...)
Company: Philips Iberica SAU
Location: Plymouth
Posted on: 02/27/2021

Senior Client Manager
Description: The primary function of the Senior Client Manager is to build and manage successful calling campaigns for Key Account clients that generate results, stay within scope and support retention while overseeing (more...)
Company: Volkart May
Location: Plymouth
Posted on: 02/27/2021

Executive Director of Health & Housing
Description: Posted: 2021-01-25 br Director of Nursing br Parks Place Memory Care - View on map - br br Parks Place a new memory care facility in Plymouth, MN, is currently seeking (more...)
Company: Care Providers of Minnesota
Location: Plymouth
Posted on: 02/27/2021

Purchasing Manager, Construction
Description: Rivian--is on a mission to keep the world adventurous forever. This goes for the emissions-free Electric Adventure Vehicles we build, and the curious, courageous souls we seek to attract.-- As a company, (more...)
Company: Via Transportation Inc
Location: Plymouth
Posted on: 02/27/2021

Research and Development Manager
Description: Group: Magna Mechatronics, Mirrors Lighting Division: Autosystems America, Inc. Job Type: Permanent/Regular Location: Plymouth, MI, US, 48170 Belleville, ON, CA Ostrava, CZ Rivoli Turin, IT Sao Paolo, (more...)
Company: Magna International Inc.
Location: Plymouth
Posted on: 02/27/2021

Senior Project Manager
Description: Are you up to the challenge At ePlus, we engineer transformative technology solutions for the most visionary companies in the world. This takes imagination, relentless client service, and the tenacity (more...)
Company: ePlus Technology, Inc.
Location: Plymouth
Posted on: 02/27/2021

Chief Medical Officer
Description: Reporting to the President the Chief Medical Officer br at Bradley Hospital is responsible for the hospital---s overall delivery of br patient care professional relations among providers and other (more...)
Company: Lifespan
Location: East Providence
Posted on: 02/27/2021

Santander Holdings USA Inc is Now Re-Hiring for Santander Holdings Usa Inc Credit Risk Manager
Description: Santander Holdings Usa Inc Credit Risk Manager - Santander Holdings USA IncCredit Risk Manager 2004134 DescriptionAs a member of Santanders retail banking division, youll help serve Santanders retail (more...)
Company: Santander Holdings USA Inc
Location: Weymouth
Posted on: 02/27/2021

Director of Health, Safety & Risk Management
Description: Director of Health, Safety Risk Management Summary: The Rhode Island Interlocal Risk Management Trust The Trust is searching for a Director of Health, Safety Risk Management . br br Posted: (more...)
Company: Association-Governmental Risk
Location: East Providence
Posted on: 02/27/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Somerville RSS job feeds