EPM Scientific
Senior Director Regulatory Affairs
EPM Scientific, San Francisco, California, United States, 94199
Base pay range
$250,000.00/yr - $300,000.00/yr
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.
Clinical-stage biopharmaceutical company advancing innovative therapies in oncology. Lead program is in late-stage development, and we are seeking an experienced regulatory leader to drive global strategy and major submissions. This is a high-impact role with visibility across executive leadership and cross-functional teams.
Key Responsibilities
Lead global regulatory strategy
for clinical development and life-cycle management of oncology programs.
Oversee preparation and submission
of regulatory filings, including INDs, CTAs, NDAs, MAAs, briefing documents, and related materials.
Serve as the regulatory subject matter expert
on cross-functional teams and provide strategic input to senior leadership.
Manage interactions with global health authorities , including leading negotiations and ensuring alignment with regulatory expectations.
Identify regulatory risks and implement mitigation strategies
to support program success.
Build and mentor a regulatory team , establish processes, and implement systems to support compliance and efficiency.
Qualifications
Education:
Bachelor's degree in a scientific discipline required; advanced degree (PharmD, PhD, MS) preferred.
Experience:
12+ years in Regulatory Affairs within pharma/biotech.
Proven track record of leading major submissions (NDA, MAA) and global regulatory strategies.
Strong oncology experience required.
Skills:
Strategic thinker with excellent leadership, communication, and cross-functional collaboration abilities.
Why Join Us?
Opportunity to shape regulatory strategy for a late-stage oncology program.
Collaborative, mission-driven environment focused on delivering transformative therapies to patients.
Competitive compensation and benefits package.
Seniority Level Director
Employment Type Full-time
Job Function Science
Industries Medical Practices
Referrals increase your chances of interviewing at EPM Scientific by 2x
San Francisco County, CA
#J-18808-Ljbffr
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.
Clinical-stage biopharmaceutical company advancing innovative therapies in oncology. Lead program is in late-stage development, and we are seeking an experienced regulatory leader to drive global strategy and major submissions. This is a high-impact role with visibility across executive leadership and cross-functional teams.
Key Responsibilities
Lead global regulatory strategy
for clinical development and life-cycle management of oncology programs.
Oversee preparation and submission
of regulatory filings, including INDs, CTAs, NDAs, MAAs, briefing documents, and related materials.
Serve as the regulatory subject matter expert
on cross-functional teams and provide strategic input to senior leadership.
Manage interactions with global health authorities , including leading negotiations and ensuring alignment with regulatory expectations.
Identify regulatory risks and implement mitigation strategies
to support program success.
Build and mentor a regulatory team , establish processes, and implement systems to support compliance and efficiency.
Qualifications
Education:
Bachelor's degree in a scientific discipline required; advanced degree (PharmD, PhD, MS) preferred.
Experience:
12+ years in Regulatory Affairs within pharma/biotech.
Proven track record of leading major submissions (NDA, MAA) and global regulatory strategies.
Strong oncology experience required.
Skills:
Strategic thinker with excellent leadership, communication, and cross-functional collaboration abilities.
Why Join Us?
Opportunity to shape regulatory strategy for a late-stage oncology program.
Collaborative, mission-driven environment focused on delivering transformative therapies to patients.
Competitive compensation and benefits package.
Seniority Level Director
Employment Type Full-time
Job Function Science
Industries Medical Practices
Referrals increase your chances of interviewing at EPM Scientific by 2x
San Francisco County, CA
#J-18808-Ljbffr