Director, Regulatory Affairs CMC
Proclinical is seeking a Director, Regulatory Affairs CMC for a leading biopharmaceutical company located in San Francisco, CA.
The Director, Regulatory Affairs, together with the VP, Regulatory Affairs, will be responsible for taking a hands-on approach to developing and implementing regulatory strategies for development programs in rare diseases.
Must be eligible to work in the US.
- Plan, coordinate, and develop high quality and compliant regulatory submissions. This may include, but may not be limited to, the drafting of key regulatory submissions, reviews of CMC, nonclinical, and
- clinical protocols and/or reports; review and approval of Investigator's Brochures, Investigational Medicinal Product (IMP) labeling, IND information amendments, IMP Dossier updates, meeting requests,
- and meeting briefing documents.
- Provide regulatory advice and information to cross-functional teams and to other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
- Leads the drafting, review, and finalization of responses to queries from Regulatory Authorities.
- Maintains up-to-date knowledge of and expertise with applicable FDA, EMA, and MHRA regulations, legislations, and guidelines as needed.
- Manages communications with Regulatory Authorities.
- Contributes to the development of regulatory plans and strategies and proposes risk mitigation strategies, as requested by the department head.
Skills and Requirements:
- A degree in a life science or closely related discipline with a higher degree preferred (e.g., MSc, MPH, PhD). A minimum of 7 years and 10 years direct regulatory affairs is required for the Associate Director and Director positions, respectively. that includes but cannot be limited to CMC regulatory. Experience in a pharmaceutical or biotech company from IND through late-stage development is required. Experience in a small company and hands-on NDA experience from preparation through submission and approval in a non-oncology, rare disease indication is strongly preferred.
- Regulatory experience development of modified-release solid oral dosage forms is highly preferred
- Established track-record of drafting, reviewing, and finalizing successful regulatory submissions and Regulatory Authority interactions as required. Recent NDA experience from late phase 3 study, pre-NDA meeting, NDA preparation through product approval is a plus.
- Proven ability to manage multiple complex projects, with the flexibility and adaptability to reprioritize workload.
- Strong experience interacting with the FDA at Type B (i.e., Pre-IND, End-of-Phase 2, Pre-NDA) and Type C meetings.
- Proven proficiency in MS Word, Excel, Power Point, Visio, Adobe Acrobat. Must have experience with document formatting templates.
- Must be a hands-on team player who thrives in a fast-paced, team environment.
- Excellent verbal, written, negotiation and interpersonal skills are required. Must be articulate and able to communicate effectively both orally and in writing with employees at all levels of the global organization and external audiences.
If you are having difficulty in applying or if you have any questions, please contact Nicholas Walker at +(1) 646-367-2908 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.