(Associate) Director, Regulatory Affairs – Permanent – San Francisco Bay Area
Proclinical is seeking an (Associate) Director, Regulatory Affairs for a clinical-stage biopharmaceutical company located in the San Francisco Bay Area.
Primary Responsibilities:
In this role, you will develop and implement regulatory strategies for their development programs in rare diseases.
Skills & Requirements:
- A degree in a life science, chemistry, or chemical engineering or closely related discipline with a graduate degree preferred and at least 10 years of experience in pharmaceutical regulatory affairs, that includes, but cannot be limited to, CMC regulatory affairs. Strong track record of contributing to regulatory submissions would be considered. Experience in a small company and in a fast-paced environment is preferred.
- Regulatory experience development of modified-release solid oral dosage forms is highly preferred, and regulatory experience in the development of small molecules is required.
- 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.
The (Associate) Director, Regulatory Affairs will:
- Responsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members.
- Contributes to the development of regulatory plans and strategies, identifies and proposes risk mitigation strategies, and influences project teams and sub teams across international site locations.
- Assist in developing and implementing strategies for the earliest possible approvals/clearance of regulatory submissions associated with assigned projects.
- 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
If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at (+1) 646-779-7961 or p.huynh@proclinical.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.
