This biotechnology company is developing vaccines for a variety of infectious diseases including HIV, HCV, Ebola, and COVID-19. The Regulatory CMC contractor will lead Regulatory CMC filings for the company’s portfolio of vaccine candidates. Reporting to the Chief Medical Officer, this individual will work closely with cross-functional subject matter experts and outside vendors to write, review, and ensure the timely submission of regulatory CMC filings. This engagement will be approximately 40 hours a week for at least six months. This is a remote role.
RESPONSIBILITIES:
- Manage and implement planning, preparation and submission of high-quality global CMC applications (INDs, CTAs, IMPDs, IBs, etc) for multiple vaccine programs.
- Effectively work with the Contract Research Organization, Contract Manufacturing Organization, and internal teams to manage regulatory CMC activities to achieve robust document preparation, standardization and approvals.
- Interpret regulations and provide well-reasoned regulatory guidance to cross functional project team.
- Drive adherence to CMC regulatory guidelines relevant for the development of vaccine products.
- Ensure that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
- Provide regulatory direction to external vendors working on CMC development to ensure timely and efficient regulatory submissions are achieved and compliant with regulatory requirements.
- Effectively plan and prioritize regulatory activities in close collaboration with leads from other functional areas to achieve the clinical development plan/timelines for each product entering phase 1 trials.
- Support or lead the preparation of health authority meeting materials and lead responses to requests for information (within a trial during regulatory/ethic review and for a CTA/IND).
- Assure compliance with all applicable domestic and international regulations including regulatory change management.
- Establish templates for Regulatory documents and filings.
- Monitor industry and regulatory trends and be able to apply learnings and provide guidance related to such trends to regulatory and functional teams. Compile and maintain regulatory files and trackers for regulatory information and submission preparation.
- Participate in establishing a CFR compliant documentation system.
EXPERIENCE AND QUALIFICATIONS:
- Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.
- At least 5 years of experience in global Regulatory Affairs CMC in the biotechnology, Clinical research organization or pharmaceutical industries.
- Experience writing CMC sections for INDs, IMPD, IB, CTAs, NDAs, BLAs, MAAs, etc.
- Must have CMC Regulatory experience for biologic programs. Prior vaccine experience a plus but not required.
- Demonstrated experience with Health Authorities, submissions, and a working knowledge of both FDA and EMA regulations, the regulators, and the approval process.
- Direct experience in IND environment required. Ex-US experience a plus.
- Proven experience and success in applying regulatory knowledge to various situations/
- Excellent operational skills including planning, organizing and the ability to deal effectively with a variety of personnel in other functional groups both internally and outside the company
- Excellent writing, communication, and interpretive skills.
- Ability to work remotely in a small, fast-paced biotech environment.
- High attention to detail, ability to work on multiple projects with tight deadlines and able to work independently.
NOTE: All applicants must be authorized to work in the US. H1B transfers cannot be accommodated.