Senior Director, Regulatory Affairs

Senior Director, Regulatory Affairs at Proclinical Staffing Senior Director, Regulatory Affairs at Proclinical Staffing in San Jose, California Posted in 7 days ago.

Type:

full-time

Job Description:

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:

In this role, you will lead global regulatory strategy and operations across the company's development pipeline. This individual will be responsible for developing and executing regulatory strategies, overseeing submission activities (INDs, CTAs, NDAs/BLAs/MAAs), and partnering with internal stakeholders and external agencies to advance programs through clinical development and regulatory review. The position is based in the San Francisco Bay Area, California in a hybrid work environment.

Skills & Requirements:

Advanced degree (PhD, Pharm

D, MD, MS

) or BS in a scientific discipline with 10+ years of regulatory affairs experience in the biotech/pharmaceutical industry, including 5+ years at the Director level or above. Demonstrated success developing and executing global regulatory strategies and leading submissions across multiple stages of drug development. Deep knowledge of US regulatory requirements (FDA), with experience in ex-US markets (e.g., EMA, Health Canada, MHRA) preferred. Hands-on experience with INDs, CTAs, NDAs, BLAs, MAAs, and regulatory agency meeting preparations. Familiarity with special regulatory designations and accelerated pathways. Experience in a fast-paced biotech or small company environment; adaptable, proactive, and collaborative. Proficiency in regulatory operations, including working with publishing vendors and eCTD submissions. Experience with RIMS tools is a plus. Experience in immunology, dermatology, or rare diseases is a plus. The Senior Director, Regulatory Affairs will: Lead the development and execution of US and global regulatory strategies to support the advancement of their 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. 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.