Manager Regulatory Affairs

from 15 to 20 year(s) of Experience
₹ Not Disclosed by Recruiter

Job Description

Roles and Responsibilities

Job Responsibilities

1. To build regulatory affairs team of the Company

2. To register products in new markets and add products to existing market

3. Should have latest updated knowledge on filing requirements of semi regulated & ROW market especially ASEAN and African market

4. Prepare, compile dossiers for non-regulated and semi regulated market

5. Resolve the queries raised by regulatory authorities from time to time

6. To review technical documents required for dossier preparation

7. To check packing material artwork and specifications

8. Organize and train on departmental SOPs

9. Coordinate with Analytical Development, Quality Control, Production,  and Stability teams to ensure timely submission of applications

10. Review, co-ordination, follow-up of legal documents COPP, PP & WHO-GMP etc

11. Responsible for submit documents, samples & replying to the queries within stipulated time as  may be raised by registering authorities


Salary: Not Disclosed by Recruiter

Industry:Pharma, Biotech, Clinical Research

Functional AreaHR, Recruitment, Administration, IR

Role CategorySenior Management

Employment Type:Full Time, Permanent

Key Skills


UG:B.Pharma in Pharmacy

PG:M.Pharma in Pharmacy


Company Profile


Incorporated In 2007, Linux Laboratories is an emerging global pharmaceutical company with Corporate office in, Chennai, India. Linux Laboratories is the Tenth largest speciality generic NEURO - PSYCHIATRIC & DERMA pharmaceutical company. We provide high-quality, affordable medicines trusted by healthcare professionals and patients all over India. Our success and growth is attributed to over 500 strong multi-cultural workforces from all over the nation. Our team has taken Linux laboratories to the heights that it has scaled and working to take it further up on its higher growth trajectory. We value our People as invaluable asset. The Culturally diverse workforce is one of our biggest strengths. The rich experience they bring, across varied skill-sets and backgrounds are instrumental.

Company Info
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Reference Id:HO/RA/04/21/001