Regulatory Affairs Manager

Position

Sr.Manager/AGM

Geographic Location

Ahmedabad (Corporate Office) Gujarat

Qualification

M. Pharm or Ph.D.

Experience

15+ years’ experience Injectable/OSD for ROW Market

Role & responsibilities:

· Devise, lead and implementation of global regulatory strategies taking into consideration the overall regulatory submission process as per country wise regulations

· Manage and monitor preparation, submission, and review of regulatory documentation in collaboration with cross functional expert and regulatory team lead.

· Managing Lifecycle of approved products based on submission and timely approved per relevant changes and timely renewal submission.

· Overseeing all aspects of regulatory processes, including product registrations, variations, renewals, and regulatory inspections. By ensuring that these processes are efficient, compliant, and aligned with business objectives.

· Facilitate regulatory support for Development of new product to commercialization level

· Guide and lead team for timely delivery of regulatory requirements.

Candidate Specification:

· Experience of 15+ years in pharmaceutical submission of injectable for ROW Market

· Must be Proactive, Organized and effective communicator with the ability to build strong relationships within team as well as cross function

· Must demonstrate strong problem solving, negotiating and leadership skills.

· Fluency and command over English language and IT tools.

· Capability in managing people in a multiple reporting matrix structures

· Capability to promote team work and collaboration among different team functions

Offered CTC up to: 38 Lacs

Candidate who are ready to relocate can also apply

Intrested candidate can share cv
[email protected]

Pay: ₹1,800,000.00 - ₹3,800,000.00 per year

Work Location: In person