Remote: Global Head of Regulatory Affairs

Regulatory Jobs; Radnor (Delaware County); Híbrido; USD 390.000 - 415.000; Jornada completa

Descripción de la vacante

Mineralys Therapeutics seeks a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercialization. You will own submissions, health authority interactions, labeling changes and post-marketing commitments, partnering with Clinical Development, Quality, CMC, and Legal.

Build and guide a high-impact regulatory team, drive end-to-end regulatory programs, and align regulatory activities with corporate growth objectives, all in a fully remote

Formación

• 15+ years regulatory affairs leadership in biopharma.
• Experience with NDA/MAA submissions and global launches.
• Strong cross-functional leadership with Clinical Development, CMC, Quality, Commercial and Legal.

Responsabilidades

• Drive the global regulatory strategy partnering with Clinical Development to shape plans and endpoints.
• Provide executive oversight for health authority interactions, labeling changes and safety updates.
• Oversee global post-approval submissions, line extensions, manufacturing variations and renewals.
• Build ex-US regulatory approach across priority markets and pursue faster pathways where appropriate.
• Lead commercialization activities and cross-functional alignment across Regulatory, Commercial, Medical Affairs, Quality, and Supply Chain.
• Build and develop a high-performing global Regulatory Affairs organization with clear accountability.

Conocimientos

Autonomy

Velocity

Data-Driven

Agile Mindset

Travel

Educación

PhD/MD/PharmD

Advanced degree preferred

Descripción del empleo

Mineralys Therapeutics seeks a Senior Vice President of Regulatory Affairs to lead global regulatory strategy across development and commercialization. You will own submissions, health authority interactions, labeling changes and post-marketing commitments, partnering with Clinical Development, Quality, CMC, and Legal.

Build and guide a high-impact regulatory team, drive end-to-end regulatory programs, and align regulatory activities with corporate growth objectives, all in a fully remote