Global Regulatory Strategy Leader, Hybrid Bay Area

EPM Scientific; San Francisco (CA); Hybrid; USD 300,000 - 400,000; Full time

Benefits offered by this job

Bonus

Equity

Benefits

Job summary

EPM Scientific is seeking a Regulatory Affairs Director/VP in the San Francisco Bay Area. This senior role focuses on driving global regulatory strategy across development programs and involves direct interactions with senior leadership and health authorities.

The ideal candidate has 12+ years in regulatory affairs, advanced degrees like PharmD or PhD, and hands-on experience with NDA/BLA approvals. The position offers a hybrid work model and a competitive salary ranging from $300,000 to $400,000 plus benefits.

Qualifications

• 12+ years in regulatory affairs within pharma or biotech.
• Proven experience with NDA or BLA submissions.
• Hands-on regulatory leadership experience.

Responsibilities

• Lead global regulatory strategy from early development through post-approval.
• Prepare NDA/BLA submissions in eCTD format.
• Conduct face-to-face meetings with FDA, EMA, and other health authorities.

Skills

Global regulatory knowledge

Strong FDA interaction history

NDA/BLA approval experience

Education

Advanced degree - PharmD, PhD, or MD

Job description

EPM Scientific is seeking a Regulatory Affairs Director/VP in the San Francisco Bay Area. This senior role focuses on driving global regulatory strategy across development programs and involves direct interactions with senior leadership and health authorities.

The ideal candidate has 12+ years in regulatory affairs, advanced degrees like PharmD or PhD, and hands-on experience with NDA/BLA approvals. The position offers a hybrid work model and a competitive salary ranging from $300,000 to $400,000 plus benefits.