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Solid Biosciences · 1 day ago

Director, Regulatory Strategy

Boston, MA

Full-time

Hybrid

Director/Executive

$190K/yr - $240K/yr

8+ years exp

Solid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates for rare diseases. The Director of Regulatory Strategy will lead global regulatory strategies and submissions, collaborate with interdisciplinary teams, and contribute to shaping the regulatory landscape for gene therapy development.

BiotechnologyGeneticsHealth CareMedical

Comp. & Benefits

Responsibilities

Actively represent Regulatory on interdisciplinary teams (e.g. Clinical Study Teams, Program Teams) and with business partners such as CROs, consultants, etc

Collaborate with cross-functional teams to generate and refine the product development strategy

Lead global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities

Coordinate and drive regulatory submissions, including necessary cross functional teams and timelines, relevant to assigned projects or programs

Actively contributes to the preparation and execution of global agency meetings

Support development and implementation of global regulatory strategies, including identifying regulatory risks, to facilitate the progress of programs through all phases of development

Lead applications for regulatory designations, such as Orphan Drug Designation, Rare Pediatric Disease Designation, and Priority Medicines applications

Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy

Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings

Qualification

Regulatory affairsGene therapy experienceIND applicationsGlobal CTAsUSEU regulationsCommunicationOrganizational skillsCreative problem solvingCollaboration skills

Required

Bachelor's degree in a scientific discipline

Minimum of 8+ years of experience in regulatory affairs in pharmaceutical/biotech, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US

Strong knowledge of US and EU regulations and Guidance's pertaining to the conduct of investigational drug studies

Ability to effectively organize and prioritize tasks to achieve established deadlines

Ability to work both independently and within project teams, committees, etc. to achieve group goals

Excellent verbal and written communication skills

Excellent organizational and program management skills that ensure timely completion of objectives by appropriate prioritization, scheduling and assignment of tasks

Strong collaborator with multi-disciplinary teams

Creative problem solving and strategizing abilities