Senior Director, Regulatory Strategy
Company: Seres Therapeutics
Location: Somerville
Posted on: January 15, 2021
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Job Description:
Seres is seeking a Regulatory Strategy Leader for multiple
products across their diverse portfolio. The chosen candidate will
have the opportunity to break new ground and be part of filing and
potentially winning approval for the first microbiome therapeutic
in the United States as well as other markets. The Sr Director
Regulatory Strategy will have a key role contributing to build a
successful clinical regulatory strategy function at Seres and will
lead key interactions between Seres and the FDA. The role includes
participation in defining and implementing the strategy from
first-in-human trial until marketing authorization and subsequent
adjustments. The Sr Director Regulatory Strategy will be
responsible for ensuring alignment on regulatory strategy,
activities, and timelines between project, product, and program
teams. A successful Senior Director of Regulatory Affairs will
build effective partnerships with counterparts across the R&D
organization, as well as external partners. Responsibilities:The
areas of responsibilities will includeParticipate in the
redefinition of the regulatory strategy for the company.Provide
regulatory support in preparation of documents such as Investigator
Brochure, clinical study protocols, and Informed Consent.Provide
regulatory advice to all stakeholders in support of the development
of clinical study reports.Plan and supervise preparation and filing
of regulatory submissions for assigned products/programs from IND
to NDA/BLA as well as Fast Track, Breakthrough, RMAT, and ODD to US
agencies and institutions.Plan, supervise, and represent Seres at
regulatory agency meetings.Interpret and explain regulatory agency
communications to stakeholders across Seres program/project teams
to ensure accurate functional area responses to agency requests and
comments.Represent Seres on co-development teams and liaison with
co-development partners on regulatory planning and
strategy.Participate in building the Regulatory Affairs team.Stay
current on changing regulatory environment, advise Seres on new and
changing regulations that may impact ongoing development programs,
and work with QA to implement new or changed operating procedures
for ongoing programs.Requirements:Industry Experience: Significant
experience in regulatory affairs within the biotech or
pharmaceutical industry, including direct experience interacting
with the FDA; experience with CBER preferred. Experience with
foreign regulatory agencies a plus.Experience with US regulatory
submissions, Orphan Drug Designation, Rolling BLA, Fast Track and
Breakthrough therapy designations in the US as well as foreign
agency equivalents considered a plus.Experience planning and
managing complex regulatory submissions.Regulatory or scientific
experience across a variety of disease areas considered a
plus.Experience collaboratively developing Target Product Profiles
is required.Experience developing and implementing a Clinical
Development Plan is required.Experience working with external
medical/scientific experts to support development planning and
strategy.Critical Skills: Strategic problem-solving
skills.Excellent organizational and multitasking abilities.A team
player with leadership skills.Superior communication
skills.Scientific curiosity strongly preferredDepartment: Clin Dev
- Regulatory Location: Cambridge, MA
Keywords: Seres Therapeutics, Somerville , Senior Director, Regulatory Strategy, Executive , Somerville, Massachusetts
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