Director/Senior Director, Regulatory Affairs
Location
Cambridge, MA | United States
Job description
COMPANY MISSION
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
POSITION SUMMARY eGenesis is seeking a Director/Senior Director of Regulatory Affairs to provide tactical and strategic leadership and ensure that all clinical, nonclinical and CMC regulatory requirements and goals are met in accordance with industry standards. In this role, you will be responsible for the preparation and submission of INDs, CTAs, IMPDs and amendments, and other regulatory submissions as required. In addition, you will be responsible for the continued development and maintenance of the RA document management system to assure proper tracking and maintenance of RA submissions and files.
The field of xenotransplantation is relatively uncharted and involves a complex relationship between the FDA Center for Veterinary Medicine (CVM) for the transgenic donor animals and the FDA Center for Biologics Evaluation and Research (CBER) for the organ product and transplantation to humans. In this role, you will leverage your Regulatory experience to assist with and lead Regulatory activities across all of the eGenesis programs. You will thrive in this role if you are energized by using strong communication and team leadership to broadly engage across the organization and if you are excited by the new challenges of bringing a relatively uncharted product to market.
PRIMARY RESPONSIBILITIES - Prepare and submit INDs and IND amendments and other regulatory submissions, as required. Coordinate with Clinical, Nonclinical, CMC and other groups to assure timely and accurate preparation of regulatory submissions
- Responsible for defining, preparing, and providing required Module 3 (CMC) content for submissions (Drug Substance, Drug Product, CoAs, specifications, Regional information, Facilities updates, Appendices, etc.)
- Author and/or review CMC development reports, batch records, and other technical reports to support the advancement of CMC development strategy
- Review information contained in regulatory submissions to assure accuracy and clarity
- Articulate complex Regulatory issues to project teams and stakeholders to support development of eGenesis xenotransplantation therapies
- Participate in and sometimes lead interactions with FDA and other regulatory authorities for assigned projects to ensure acceptance, review, and approval of INDs, INADs, NADAs, BLAs, amendments
- Develop and maintain relationships with regulatory authorities, internal departments, CROs/CMOs, and other partners
- Provide oversight/perform set up and maintenance of regulatory files and submission archives to assure proper storage and retrieval of regulatory documentation
- Preparation and maintenance of regulatory submission trackers and notification to and coordination with team members for upcoming submissions
- Provide regulatory oversight in the preparation and review of draft and final submissions/reports
- Maintain a working knowledge in the specific areas related to GCP, GLP and GMP compliance including, but not limited to regulatory and ICH requirements
- Support the communication and interpretation of current and new regulations
BASIC QUALIFICATIONS - Bachelor's Degree with 12+ years of experience working at a CRO, a Sponsor company, or in the pharmaceutical/biopharmaceutical industry
- Requires knowledge of U.S. Federal Regulations related to clinical research (21 CFR Parts 50, 56, 312), ICH guidelines, and a familiarity with GLP and GMP requirements and guidelines (21 CFR 58, 210 and 211)
- A strong knowledge of submission compilation in eCTD format
- Experience with CBER, CDER, and/or CVM preferred
- Excellent communication and writing skills
- Hands-on, roll-up-your-sleeves approach with the ability to simultaneously handle multiple project issues while dealing with time demands, incomplete information, or unexpected events
- Understanding of GMP/manufacturing requirements
- Understanding of the drug and biologics development process
- Experience with preparation of meeting requests and submissions, including the generation of CMC content (eg, VIP, INTERACT, pre-IND, IND, BLA)
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