A clinical-stage biopharmaceutical company based in Redwood City, California, is developing novel therapeutics for the treatment of rare diseases. We are seeking a highly motivated and enthusiastic individual to join our growing regulatory affairs group. Together with the Regulatory Affairs team and in close collaboration with other departments, the Associate Director / Director, Regulatory Affairs will take a hands-on approach to developing and implementing regulatory strategies for our development programs in rare diseases. The Associate Director / Director, Regulatory Affairs will be based at our office in Redwood City, CA in a primarily hybrid work environment to foster a strong team and collaborative dynamic.

Responsibilities

• Responsible for strategic and operational regulatory input and support for collaboration with other project team members, including regulatory team members.
• Contribute to the development of regulatory plans and strategies, identify and propose risk mitigation strategies, and influence 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.
• Prepare and/or manage submissions that may be technically complex and require extensive interaction with departments outside of regulatory affairs.
• Provide regulatory advice and information to cross-functional teams and other functional areas (i.e., CMC, nonclinical, and clinical) for product development and planning to support the timely achievement of company and department goals.
• Lead the drafting, review, and finalization of responses to queries from Regulatory Authorities.
• Maintain knowledge of regulatory requirements up to date and communicate changes in regulatory information to other departments.

Qualifications

• A degree in life science, chemistry, chemical engineering, or a closely related discipline, with a graduate degree preferred, and at least 10 years of experience in pharmaceutical regulatory affairs, including but not limited to CMC regulatory affairs. A strong track record of contributing to regulatory submissions is preferred.
• Experience in a small company and fast-paced environment is desirable.
• Proven proficiency in MS Word, Excel, PowerPoint, Visio, and Adobe Acrobat, with experience using document formatting templates.
• Regulatory experience in the development of modified-release solid oral dosage forms is highly preferred, and experience with small molecule development is required.
• A demonstrated track record of drafting, reviewing, and finalizing successful regulatory submissions and interactions with Regulatory Authorities is essential. Recent NDA experience from late-phase 3 studies, pre-NDA meetings, NDA preparation, through product approval is a plus.
• Proven ability to manage multiple complex projects with flexibility and adaptability to re-prioritize workloads.
• 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.

Salary Range : $170,000–$250,000