Urgent requirement M.Sc. / M.Pharm / B.Pharm for Embio Limited

Urgent requirement for Embio Limited, an reputed Pharma API company

We are looking for candidate as Executive / Assistant Manager in our Regulatory Affairs department

Location : Powai, Mumbai (5 days working)

Educational qualification:

M.Sc. / M.Pharm / B.Pharm

Work experience

8 to 12 yrs experience in RA function with knowledge in preparing DMF for regulated & non regulated market and handling queries / deficiencies

Job Description

– Preparation of DMF for regulated and non regulated market
– Should be able to handle queries / deficiencies independently
– Communicate regulatory information to multiple departments and ensure that information is interpreted correctly
– Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
– Provide responses to regulatory agencies regarding product information or issues.
– Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
– Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations

Interested candidates can send their profile mentioning current CTC, expected CTC and notice period to Yogesh Raje – yogesh.raje@embio.co.in