Senior Director, Regulatory Strategy
Posted on Apr 6, 2021 by Seres Therapeutics, Inc.
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.
The areas of responsibilities will include
Participate 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.
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.
Strategic problem-solving skills.
Excellent organizational and multitasking abilities.
A team player with leadership skills.
Superior communication skills.
Scientific curiosity strongly preferred