San Francisco, CA
9 months ago
Manager/Senior Manager, Regulatory Affairs
San Francisco, CA
Full Time Permanent
A Clinical Stage Biopharmaceutical company in the San Francisco Bay Area is looking to hire a new Manager or Senior Manager of Regulatory Affairs to join their extensive regulatory team to help in the approvals of drugs for treatment of cancer, autoimmune disease and chronic pain. This is an excellent opportunity to get into a Senior Manager role with a growing company.
The Manager/Senior Manager, Regulatory Affairs will be responsible for supporting the Regulatory department across a number of projects. This professional will be responsible for compiling and revising regulatory dossiers. A strong candidate would be a professional with 4-6 years of experience in Regulatory Affairs working on IND and NDA/BLA submissions qwith some experience being in the Oncology space.
- Organize, prepare, maintain and revise regulatory submissions for review in support of investigational and new device and/or drug applications, and post-approval submissions, for US and ROW (e.g., 510(K), IDE, IND, NDA, CTD, CTA, IMPD, MAA, Drug/ Device Master Files, Technical Files, Annual Reports, Amendments, Supplements, and etc.)
- Ensures that submissions are in accordance with regulatory requirements (i.e., US, ICH).
- Reviews specifications, methods, SOPs, protocols, reports, labeling, and etc. for regulatory compliance.
- Participate in and provide regulatory guidance to working teams (both internal and partnered programs).
- Perform research and compile materials to develop regulatory strategies.
- Collaborate with management in order to provide input on timelines for submissions.
- Bachelors degree
- 4-6 years of experience in Regulatory Affairs for drugs or medical devices
- Previous experience working on IND/NDA/BLA submissions
- Oncology experience highly preferred
- Must be able to adhere to strict project timelines.
- Knowledge and current awareness of US, and knowledge of ROW regulatory requirements, guidelines and regulations (i.e., cGXP).