Senior Director Regulatory Affairs

Senior Director, Regulatory Affairs – Permanent – San Francisco, CA

Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the San Francisco Bay Area, California.

Primary Responsibilities

Lead global regulatory strategy and operations across the company’s development pipeline.

Develop and execute regulatory strategies, oversee submission activities (INDs, CTAs, NDAs, BLAs, MAAs), and partner with internal stakeholders and external agencies to advance programs through clinical development and regulatory review.

• Lead the development and execution of US and global regulatory strategies to support the advancement of investigational products from preclinical through late‑stage development.
• Serve as the regulatory lead on cross‑functional project teams, providing regulatory guidance to ensure alignment with clinical, CMC, nonclinical, and corporate goals.
• Oversee preparation, submission, and maintenance of high‑quality regulatory documents (e.g., INDs, CTAs, amendments, briefing books, meeting requests, and responses to health authority queries).
• Manage interactions with regulatory authorities (FDA and ex‑US) including leading or supporting meeting preparations and correspondence.
• Evaluate regulatory risks and provide mitigation strategies to support timely development and approvals.
• Provide regulatory guidance on special designations (e.g., Orphan Drug, Fast Track, Breakthrough Therapy) and expedited pathways, as applicable.
• Support regulatory activities related to CMC, nonclinical, and pharmacovigilance to ensure comprehensive submission packages.

Skills & Requirements

Contact

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.

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