5 - 7 years
Posted 167 days ago
Associate Director/Director, CMC Regulatory Affairs
Location: Bedford MA
Job Code CMC RA-0015-17
Act as the primary regulatory contact for all Homology Medicine’s Chemistry Manufacturing and Controls (CMC) regulatory strategies, issues and submissions worldwide. Act as senior CMC regulatory lead on assigned projects by coordinating regulatory workflow, providing regulatory support to the team, and tracking project timelines. Provide ongoing CMC regulatory support to the project teams. Normally receives limited supervision.
Principal Duties and Responsibilities
Provide in-depth strategic & technical advice regarding CMC development requirements for gene therapy/gene editing products per US, EU and Japanese regulations.
Provide regulatory review & feedback on all key CMC documentation.
Interface with manufacturing contractors, Homology Medicines affiliates/partners, and regulatory authorities as appropriate on CMC related issues.
Present regulatory/technical information at internal and external (e.g FDA) meetings.
Under limited supervision, design and complete CMC regulatory development plans for assigned projects, and interface with manufacturing contractors and affiliates as needed.
Design and complete/compile CMC regulatory development plans and regulatory submissions.
Participate in Regulatory Affairs initiatives aimed at improving internal Homology Medicines standards and systems.
Conduct critical reviews of key CMC technical documents to ensure the completeness, scientific accuracy, regulatory compliance, and consistency with other key documents.
Establish comprehensive CMC regulatory submission processes and flows within Homology Medicines to enable quality CMC regulatory submission sections (INDs, IMPDs, CTAs, BLAs, CTDs). Ensure CMC regulatory timelines are properly established, maintained, and on-target.
Prepare, review, and compile CMC sections of regulatory applications including investigational and marketing applications (IND, IMPD, CTA, BLA, MAA, etc.), amendments, supplements, periodic reports, annual reports, and drug master files.
Summarize, tabulate, and format technical information per regulations/guidelines to support regulatory applications.
Provide internal CMC training to relevant Homology Medicine’s personnel.
Knowledge, Skills, and Ability
Bachelors/Masters Degree in a scientific discipline, or equivalent with a minimum of experience in CMC regulatory affairs (5-8years) in the pharmaceutical industry. Ph.D. considered a plus.
Experience in the development of CMC regulatory strategy and submissions for gene therapy/gene editing and/or biologics products in accordance with US and EU regulatory guidance
Requires extensive experience and knowledge of CMC regulatory submissions requirements in the US, Canada and Europe. Understanding and experience with Asian submissions a plus.
Requires extensive experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.).
Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.).
Non-clinical pharmacology/toxicology experience is beneficial.
Interested Candidates should forward CV and cover letter to or apply on line @www.homologymedicines.com
Homology Medicines, Inc. (HMI) has built foundational intellectual property on gene editing and gene therapy vectors derived from naturally occurring human adeno-associated viruses (AAVs). The Company's technology is precise, on-target and highly efficient for in vivoediting of genetic mutations. This transformative platform technology, combined with an elite leadership team of biopharmaceutical industry veterans, create a significant opportunity for HMI to rapidly advance a diverse pipeline of new medicines that address and potentially cure the underlying cause of genetic diseases.