EPM Scientific
Vice President/Senior Vice President Regulatory Affairs
EPM Scientific, San Diego, California, United States, 92189
Vice President/Senior Vice President Regulatory Affairs
This range is provided by EPM Scientific. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range $300,000.00/yr - $425,000.00/yr
Direct message the job poster from EPM Scientific
Recruitment Consultant at EPM Scientific | Building the teams behind the next breakthroughs in healthcare Senior Vice President / Vice President, Regulatory Affairs
About
Our client is a clinical-stage biopharmaceutical company focused on overcoming treatment resistance in oncology through precision small-molecule therapies. With multiple late-stage programs in high-value indications, they are entering a critical growth phase with Phase 3 readiness and commercialization on the horizon.
The Role
This is a senior leadership position responsible for defining and executing global regulatory strategy across all development stages. You will oversee regulatory submissions worldwide, lead interactions with health authorities, and build a high-performing regulatory organization that supports multiple programs through approval and launch.
Key Responsibilities
Develop and implement global regulatory strategies for late-stage oncology programs
Lead major submissions (IND, CTA, NDA/BLA, MAA) and ensure compliance with global requirements
Serve as primary contact for FDA and other health authorities; manage regulatory negotiations
Provide strategic input on clinical development plans, lifecycle management, and post-approval activities
Build, mentor, and scale the regulatory affairs team
Oversee regulatory operations, CMC, and diagnostics functions
Advise on regulatory due diligence for business development opportunities
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field
15+ years of regulatory affairs experience in biopharma, with at least 10 years in oncology
Proven track record leading NDA/BLA/MAA submissions through approval
Experience with global health authority interactions and late-stage development
Strong leadership skills with ability to build and manage teams
Familiarity with electronic submissions (eCTD) and global regulatory frameworks
Why This Opportunity Stands Out Our client is pioneering therapies that address resistance biology, an area with significant unmet need and market potential. Backed by strong funding, partnerships, and a leadership team with a history of successful oncology approvals, this is a chance to shape the regulatory vision for a company at a major inflection point.
Interested in learning more? Contact us for a confidential discussion. Seniority level
Executive
Employment type
Full-time
Job function
Management
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at EPM Scientific by 2x
Get notified about new Vice President Regulatory Affairs jobs in San Diego, CA.
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Base pay range $300,000.00/yr - $425,000.00/yr
Direct message the job poster from EPM Scientific
Recruitment Consultant at EPM Scientific | Building the teams behind the next breakthroughs in healthcare Senior Vice President / Vice President, Regulatory Affairs
About
Our client is a clinical-stage biopharmaceutical company focused on overcoming treatment resistance in oncology through precision small-molecule therapies. With multiple late-stage programs in high-value indications, they are entering a critical growth phase with Phase 3 readiness and commercialization on the horizon.
The Role
This is a senior leadership position responsible for defining and executing global regulatory strategy across all development stages. You will oversee regulatory submissions worldwide, lead interactions with health authorities, and build a high-performing regulatory organization that supports multiple programs through approval and launch.
Key Responsibilities
Develop and implement global regulatory strategies for late-stage oncology programs
Lead major submissions (IND, CTA, NDA/BLA, MAA) and ensure compliance with global requirements
Serve as primary contact for FDA and other health authorities; manage regulatory negotiations
Provide strategic input on clinical development plans, lifecycle management, and post-approval activities
Build, mentor, and scale the regulatory affairs team
Oversee regulatory operations, CMC, and diagnostics functions
Advise on regulatory due diligence for business development opportunities
Qualifications
Advanced degree (PhD, PharmD, MD, or MS) in life sciences or related field
15+ years of regulatory affairs experience in biopharma, with at least 10 years in oncology
Proven track record leading NDA/BLA/MAA submissions through approval
Experience with global health authority interactions and late-stage development
Strong leadership skills with ability to build and manage teams
Familiarity with electronic submissions (eCTD) and global regulatory frameworks
Why This Opportunity Stands Out Our client is pioneering therapies that address resistance biology, an area with significant unmet need and market potential. Backed by strong funding, partnerships, and a leadership team with a history of successful oncology approvals, this is a chance to shape the regulatory vision for a company at a major inflection point.
Interested in learning more? Contact us for a confidential discussion. Seniority level
Executive
Employment type
Full-time
Job function
Management
Industries
Biotechnology Research and Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at EPM Scientific by 2x
Get notified about new Vice President Regulatory Affairs jobs in San Diego, CA.
#J-18808-Ljbffr