Job Description
Job Title: Director/Sr Director, Regulatory CMC
Reports to: Chief Regulatory Officer
Summary:
Solid Biosciences is seeking a Director/Sr. Director of Regulatory CMC based in Charlestown (with a hybrid option). We are seeking a creative and agile regulatory professional who is eager to be a part of a collaborative team with a goal to provide Regulatory CMC leadership for a dynamic portfolio of viral vector gene therapy programs. The candidate will play a key role in CMC-focused Agency interactions, submission writing, and innovative regulatory CMC strategies that support gene therapy development.
The successful candidate will provide global Regulatory CMC strategic guidance and tactical support to development and CMC teams with regard to regulatory requirements, regulatory interactions, and submissions for CMC activities. In addition to contributing to the internal Regulatory CMC activities, we are seeking a candidate with strong interest in participating in trade organizations to contributing to shape the broader cell & gene therapy regulatory community.
Key Duties & Accountabilities:
• Actively represent Regulatory CMC and provide regulatory expertise as a member of interdisciplinary teams (e.g. CMC Teams, Program Teams) and with business partners such as CDMOs, consultants, etc.
• Collaborate with cross-functional teams to generate and refine the product development strategy.
• Lead preparation of high-quality global clinical trial applications in the US, EU and ROW including the preparation of CMC content of initial INDs/CTAs and amendments, GMO applications, responses to agency questions, and maintenance activities.
• Coordinate and drive regulatory CMC submissions, including assembling necessary cross functional teams and timelines relevant to assigned projects or programs.
• Actively contribute to the preparation and execution of global agency meetings.
• Work closely and creatively with technical teams to support the implementation of manufacturing and analytical development strategies.
• Identify and clearly communicate regulatory CMC risks and opportunities to both the technical team and Regulatory teams. Develop and implement global regulatory CMC strategies that maximize probability of success.
• Support the development and refinement of internal regulatory processes and standards.
• Actively monitor regulatory policy and intelligence and disseminate information to inform program strategy.
• Monitor the development of new requirements, guidelines and trends through information gathering and participation in industry groups.
• Represent Solid Bio Regulatory through participation in pharmaceutical trade groups and meetings.
Core Competencies Required:
• Excellent verbal and written communication skills.
• Ability to interact effectively in a matrixed project team environment
• 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.
• Strategic thinker with a forward-looking perspective
• High level of initiative and commitment
Knowledge: Education, Experience, & Skills:
• Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred.
• Minimum of 5+ years of relevant experience in CMC Regulatory Affairs for biologics, including IND activity, global CTAs, DSURs and Agency briefing documents in US and ex-US.
• Experience in gene therapy, cell therapy or nucleic acid based therapeutic programs a plus, although not required.
• Strong knowledge of current Good Manufacturing Practices (GMP), US and EU drug and biologic regulations and guidelines including ICH, FDA and EMA guidelines.
• 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.
Travel Commitment: Minimal travel required
*We are not accepting agency resumes at this time*
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