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:

Bachelor's or Master's degree in Pharmacy, Life Sciences, or related field.

Minimum 12 years of progressive experience in US pharmaceutical regulatory affairs.

Strong knowledge of FDA regulatory requirements and drug development processes.

Proven track record in successful US product approvals and regulatory submissions (ANDA, NDA).

Excellent leadership, communication, and project management skills.

Ability to work effectively in a global, matrixed environment.

Why Join Us:

Opportunity to lead regulatory affairs for innovative pharmaceutical products.

Collaborative and growth-oriented work culture.

Competitive compensation and benefits package.

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.