Officer / Executive - Regulatory Affairs
1 Nos.
93117
Full Time
2.0 Year(s) To 10.0 Year(s)
2.00 LPA TO 5.00 LPA
Production / Quality / Maintenance
B.Pharma - Pharmacy; B.Sc - Chemistry; M.Pharma - Pharmacy; M.Sc / MS Science - Chemistry; M.Sc / MS Science - Organic Chemistry
Job Description:
- Preparation and review the dossier of as per current prescribed guidelines of the respective regulatory authority.
- Well versed with the guidelines of ICH and other regulatory.
- Preparation of documents for license application.
- Preparation of documents for COPP, FSC and other legal documents including product permission
- Preparation of registration documents as per ACTD , CTD , country format / Review / Preparation & Compilation
- Preparation of text matter and checking of artworks.
- Should coordinate with factory for samples, working standards, document data, license related documents.
- Should have knowledge with regard to checking of samples.
- Courier of documents and samples to the respective customer.
- Maintaining status and record of dossiers, samples legal documents.
Key Skills :
Company Profile
--- --- finds its roots in 4 years of engineering during which we saw a dream to carve out a niche for ourselves in Pharmaceutical Industry. As a part of the final year project, We worked on cost reduction of "Aceclofenac" which fetched us four national awards including one from Consultancy Development Center, Government of India.
At ---, We aim to develop and provide quality,cost effective and sustainable solutions to our Customers by empowering people to think beyond the traditional norms of Chemistry and Engineering to come up with different and innovative solutions to the problems.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.