Senior Manager Regulatory Affairs

Umedica Laboratories is seeking an experienced and dynamic Sr. Manager for USA Regulatory Affairs to join our global regulatory team. This is a pivotal role responsible for leading regulatory strategies, submissions, and compliance activities for pharmaceutical products in the US market.

Key Responsibilities :

• Lead regulatory submissions and maintenance activities to US FDA standards.
• Develop and implement regulatory strategies aligned with business goals.
• Manage communication and negotiations with regulatory authorities.
• Collaborate cross-functionally with clinical, quality, and manufacturing teams.
• Ensure compliance with all applicable FDA regulations, guidelines, and internal SOPs.
• Support product lifecycle management and commercial launch initiatives.

Qualifications :

Why Join Us :

If you are a strategic regulatory professional passionate about making a global impact, we invite you to apply and be a vital part of Umedica Laboratories' success.

Skills Required

ANDA, Regulatory Submissions