AD/Director Regulatory Affairs

Meets clinical-stage biopharmaceutical client based in the Bay Area is seeking a highly motivated individual to join their growing regulatory affairs group. The Associate Director / Director, Regulatory Affairs will work closely with the Regulatory Affairs team and other departments to develop and implement regulatory strategies for the company's rare disease development programs. The position will be onsite 3x per week.

Responsibilities:

Providing strategic and operational regulatory support for collaboration with project team members, including regulatory colleagues.

Contributing to regulatory plans and strategies, proposing risk mitigation strategies, and influencing project teams across international locations.

Assist in the development and implementation of strategies for early regulatory approvals, preparing and managing technically complex submissions, offering regulatory advice to cross-functional teams, leading the drafting of responses to regulatory queries, and staying updated on regulatory requirements to communicate changes to other departments.

Qualifications:

Life Sciences Degree (MSc, MPH, PhD - preferred)

10 years of experience in pharmaceutical regulatory affairs, specifically in CMC regulatory affairs, with a strong track record in contributing to regulatory submissions.

Experience in small company settings and fast-paced environments is preferred.

Proficiency in MS Word, Excel, PowerPoint, Visio, and Adobe Acrobat, along with experience in document formatting templates, is necessary.

Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience with small molecule development is required.

Send a copy of your updated resume to to discuss the details further.