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Solid Biosciences · 1 week ago

Associate Director, Regulatory CMC

Boston, MA

Full-time

Hybrid

Lead/Staff, Director/Executive

$170K/yr - $220K/yr

4+ years exp

Solid Biosciences is a precision genetic medicine company focused on advancing gene therapy candidates for rare diseases. The Associate Director of Regulatory CMC will lead regulatory CMC efforts for gene therapy drug development, engage with regulatory agencies, and collaborate with cross-functional teams to ensure compliance and strategic progress of programs.

BiotechnologyGeneticsHealth CareMedical

Comp. & Benefits

Responsibilities

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

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

Lead CMC content for global clinical trial applications including the preparation of INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities. Prepare for later stage submission activities

Interface with CMC and quality teams, including execution of change management and data integrity processes

Drive and contribute to regulatory CMC content and submissions, including necessary cross functional teams and timelines, relevant to assigned projects or programs

Actively contribute to the preparation and execution of global agency meetings

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

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

Qualification

Regulatory affairsCMC developmentGene therapy experienceIND submissionsChange managementUSEU regulationsCommunicationOrganizational skillsCreative problem solvingCollaboration

Required

Bachelor's degree in a scientific discipline

Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech, including IND activity, global CTAs, BLAs/MAAs and Agency briefing documents in US and ex-US

Knowledge of recombinant manufacturing processes and controls required, with preference for mammalian culture processes

Strong knowledge of US and EU regulations and Guidances pertaining to the CMC aspects of biological product development

Experience in submission management and change management required

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, including face to face and remote interactions

Excellent verbal and written communication skills

Ability to author and edit CMC content

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