Proclinical Staffing
Senior Director Regulatory Affairs
Proclinical Staffing, San Francisco, California, United States, 94199
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Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV. This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $250,000.00/yr - $275,000.00/yr Direct message the job poster from Proclinical Staffing 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, PharmD, 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. Seniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionScience IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Proclinical Staffing by 2x Get notified about new Director of Regulatory Affairs jobs in
San Francisco Bay Area . Vice President / Head of Regulatory Affairs San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702 Palo Alto, CA $225,000.00-$240,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Associate Director, Regulatory Affairs - Global Labeling Foster City, CA $165,495.00-$235,620.00 3 days ago Executive Director, Regulatory Affairs CMCSenior Director, Regulatory Affairs - Job ID: 1668 Palo Alto, CA $260,000.00-$280,000.00 1 hour ago Senior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 1 week ago Associate Director of Regulatory Affairs Foster City, CA $210,000.00-$225,000.00 1 week ago Director, Regulatory Affairs and Quality AssuranceAssociate Director, Regulatory Affairs - Global LabelingGlobal Head of Quality and Regulatory Affairs, Lingo Alameda, CA $193,300.00-$386,700.00 2 days ago Director, CMC Regulatory Affairs – BiologicsDirector, Global Regulatory Affairs - NeurosciencesDirector, Quality Assurance and Regulatory Affairs San Jose, CA $201,000.00-$251,000.00 1 week ago Associate Director Regulatory Affairs – APAC - Diabetes Care Alameda, CA $146,700.00-$293,300.00 22 hours ago San Francisco, CA $182,000.00-$227,100.00 6 days ago Director, Corporate Quality Management Systems Santa Cruz, CA $165,607.89-$248,411.84 1 month ago South San Francisco, CA $196,000.00-$240,000.00 5 days ago Santa Clara, CA $195,000.00-$225,000.00 2 days ago Sunnyvale, CA $143,400.00-$197,100.00 2 weeks ago Sunnyvale, CA $143,400.00-$197,100.00 2 weeks ago Commercial Regulatory Affairs Director (Advertising and Promotion) Alameda, CA $167,500.00-$237,500.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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Apply promptly! A high volume of applicants is expected for the role as detailed below, do not wait to send your CV. This range is provided by Proclinical Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more. Base pay range $250,000.00/yr - $275,000.00/yr Direct message the job poster from Proclinical Staffing 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, PharmD, 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. Seniority level
Seniority levelNot Applicable Employment type
Employment typeFull-time Job function
Job functionScience IndustriesBiotechnology Research and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Proclinical Staffing by 2x Get notified about new Director of Regulatory Affairs jobs in
San Francisco Bay Area . Vice President / Head of Regulatory Affairs San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702 Palo Alto, CA $225,000.00-$240,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Associate Director, Regulatory Affairs - Global Labeling Foster City, CA $165,495.00-$235,620.00 3 days ago Executive Director, Regulatory Affairs CMCSenior Director, Regulatory Affairs - Job ID: 1668 Palo Alto, CA $260,000.00-$280,000.00 1 hour ago Senior Director, Global Regulatory Affairs Foster City, CA $270,000.00-$285,000.00 1 week ago Associate Director of Regulatory Affairs Foster City, CA $210,000.00-$225,000.00 1 week ago Director, Regulatory Affairs and Quality AssuranceAssociate Director, Regulatory Affairs - Global LabelingGlobal Head of Quality and Regulatory Affairs, Lingo Alameda, CA $193,300.00-$386,700.00 2 days ago Director, CMC Regulatory Affairs – BiologicsDirector, Global Regulatory Affairs - NeurosciencesDirector, Quality Assurance and Regulatory Affairs San Jose, CA $201,000.00-$251,000.00 1 week ago Associate Director Regulatory Affairs – APAC - Diabetes Care Alameda, CA $146,700.00-$293,300.00 22 hours ago San Francisco, CA $182,000.00-$227,100.00 6 days ago Director, Corporate Quality Management Systems Santa Cruz, CA $165,607.89-$248,411.84 1 month ago South San Francisco, CA $196,000.00-$240,000.00 5 days ago Santa Clara, CA $195,000.00-$225,000.00 2 days ago Sunnyvale, CA $143,400.00-$197,100.00 2 weeks ago Sunnyvale, CA $143,400.00-$197,100.00 2 weeks ago Commercial Regulatory Affairs Director (Advertising and Promotion) Alameda, CA $167,500.00-$237,500.00 1 week ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
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