Director Regulatory Affairs
Company: Riot Games
Posted on: February 26, 2021
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
- Represents the Regulatory Affairs function on program
- 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
- 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
- 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
- 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
- Ability to work in a matrix environment with cross-functional
teams including a variety of scientific disciplines, bioprocess and
- 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
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