Job Description

The mission of the

Regulatory Affairs Specialist (RAS)

is to prepare and file demands for regulatory approval of the products of one's company. Biotechnology companies, which have lesser means than large pharmaceutical companies, prioritize experienced candidates or else turn to consultants. The Regulatory Affairs Specialist in biotechnology thus plays a very strategic role and is involved in all stages of the process, whereas its counterpart in the pharmaceutical industry has more delineated responsibilities, involving more administrative tasks.

The

Regulatory Affairs Specialist

stays with the same company for an average of 10 to 15 years; the rate of turnaround is therefore low. Networking is very much encouraged, through joining various associations to participate in conferences and exhibitions, and also to access current literature. Presently, there is a strong demand for Regulatory Affairs Specialists in medical device companies.

Main duties of the regulatory affairs specialist

Prepare, coordinate and supervise regulatory submissions Review product conformance and assure compliance Implement different strategies in order to meet evolving regulatory initiatives Register products according to provincial guidelines and regulations of third party suppliers Keep current with regulations Participate in conferences and interdepartmental meetings
Job Types: Full-time, Permanent, Fresher

Pay: ₹25,242.20 - ₹43,755.49 per month

Benefits:

Cell phone reimbursement Health insurance Provident Fund Work from home
Work Location: In person