Head of Regulatory Affairs & Strategy (Remote)

Mineralystherapeutics; United States; Remote; USD 390,000 - 415,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401K

Incentive plans

Job summary

Mineralys Therapeutics, a fully remote biopharmaceutical company, seeks a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercial portfolios.

The role owns end-to-end regulatory functions, shapes submission strategy, maintains agency relationships, and ensures lifecycle compliance. 15+ years in regulatory affairs with NDA/MAA experience is required; advanced degree preferred.

Qualifications

• 15+ years of progressively responsible Regulatory Affairs experience in biopharma.
• Experience leading regulatory strategy and teams.
• NDA submissions and major health authority interactions; MAA experience preferred.

Responsibilities

• Drive global regulatory strategy with Clinical Development to shape plans, trial designs, and endpoints.
• Oversee health authority interactions, labeling changes, and post-approval submissions.
• Develop ex-US regulatory approach across priority markets and align with cross-functional teams.

Skills

Regulatory strategy

Cross-functional leadership

Executive communications

Regulatory submissions

Education

Advanced degree (PharmD/PhD/MD)

Job description

Mineralys Therapeutics, a fully remote biopharmaceutical company, seeks a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercial portfolios.

The role owns end-to-end regulatory functions, shapes submission strategy, maintains agency relationships, and ensures lifecycle compliance. 15+ years in regulatory affairs with NDA/MAA experience is required; advanced degree preferred.