Asst. Manager / Manager - Regulatory Affairs (Domestic Market)

Company: Leeford Healthcare Ltd.

https://www.leeford.in/

Position:

Job location:

Experience

Job Profile:

Ø Review of labels of Drugs and ensuring their full compliance with the applicable Rules and Regulations.

Ø Handling and responding to all the product specific queries.

Ø Performing Root cause and analysis and preparing replies to the show cause notices

domestic regulatory requirements.

Ø Co-ordination with respective departments.

Ø Maintaining familiarity with company product ranges.

Ø Keeping up to date with changes in regulatory legislation and guidelines.

Ø Ensuring that quality standards are met and submissions meet strict deadlines.

Ø Maintain high levels of accuracy, meet tight deadlines.

Ø Management of Data.

Required Candidate profile

Ø Candidate should have min 5 yrs. of experience in Regulatory Affairs

Ø Experience in Domestic Markets.

Ø Candidate should be well versed with Drug Regulatory Compliances.

Ø Can handle or manage a team.

Ø Candidate should be able to review the COAs received from various companies

Ø Candidates should be able to review artworks related to Drugs.

Ø Candidate should have good knowledge about Legal Metrology regulations

Interested one can share resume to talent@leeford.in or can whatsapp to 9875961129