4D Molecular Therapeutics, located in Emeryville is a global leader in gene therapy product research & development using scientific innovation to unlock the full potential of gene therapy for patients with genetic diseases. At 4D Molecular Therapeutics (4DMT), our goal is to design and develop transformative gene therapy products using our proprietary adeno-associated virus variants platform to treat serious unmet medical conditions.
We seek an experienced Associate Director/Director, Regulatory Affairs, CMC to oversee regulatory CMC activities and maintain the regulatory CMC applications. In addition, you will be responsible for executing the regulatory CMC strategy of submissions to the US FDA, EMA, and other regulatory authorities, as well as managing interactions with regulatory authorities on CMC issues. You will be principal in aiding in development of a CMC Regulatory function for 4DMT. This position reports directly to the Chief Technical Officer and Head of Regulatory & Quality.
Specific Responsibilities include (but are not limited to):
- Implement regulatory CMC strategy for early and late stage clinical product candidates to attain rapid regulatory approvals.
- Lead and drive CMC content development for submission activities (planning, authoring, reviewing, coordination, submission) for original INDs, IND amendments, investigational medicinal product dossiers (IMPD) for inclusion in Clinical Trial Applications, BLAs and MAAs.
- Help in building a world-class Regulatory CMC function to meet 4DMT growing pipeline.
- Serve as RA CMC liaison with various internal functions (e.g., Manufacturing, R&D, Clinical Development, etc.).
- Participate in multidisciplinary efforts to prepare CMC updates for regulatory documents including IND CMC updates, Regulatory Authority meetings briefing documents, etc.
- Aid in development of regulatory dossier in support of 4DMT products in development for worldwide submissions.
- Respond to CMC queries to advance 4DMT clinical programs.
- Aid in establishing, managing, and maintaining a knowledge base of current and emerging CMC regulatory requirements, guidelines, and best practices.
- Assure compliance with regulatory standards and guidance documents, including ensuring that CMC-related changes are reported to authorities in accordance with regulatory requirements.
- Conduct risk assessments of global CMC regulatory issues.
- Maintain and continue to build 4DMT’ excellent reputation with the regulatory authorities.
- Indirectly supervise employees through a dotted line structure or via other subordinate managers.
- BS/MS degree (PhD highly desirable) in related discipline and 10 years of related experience with at least 5 years at a manager or above role.
- Experience and a proven track record of successes in biological drug submissions (e.g., IND, BLA, MAA), is preferred.
- Experience with biologics required, with experience in cell/gene therapy drug development highly desirable.
- Knowledge of the drug development process and global regulations and requirements required.
- Strong oral and written communication skills, with demonstrated ability to present ideas, information and data effectively via one-on-one discussions, team meetings and partnership interactions, including presentations.
- Strong analytical, problem-solving and organizational skills.
- Ability to prioritize and multi-task, supporting more than one project simultaneously. Ability to work in a team-based environment, cooperatively and supportive of multiple viewpoints and approaches.
- Develop departmental policies and oversee and/or authorize their implementation.
- Strong knowledge of cGMP (FDA, ICH, and ISO) requirements and FDA regulatory guidelines.
- Flexible and able to work independently in a dynamic and changing company environment.
- Established track record of Regulatory CMC and Compliance decision-making.
- Experience with close collaboration with R&D, Clinical Operations, and Manufacturing/Supply Chain.
- Focus on practical, common-sense, creative, and sensible approaches to finding effective solutions.
- Ability to travel (10%).
Qualified candidates may submit a resume and cover letter to email@example.com. The level of this position will be based on the final candidate’s qualifications.