Officer / Executive - Regulatory Affairs
1 Nos.
77616
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
--- Parenterals Ltd. is a Gujarat based pharmaceutical company, established in 1992 by Mr. Ramesh Desai, who started the company with a vision of making world class affordable medicines and to take it to the forefront of contract manufacturing units in Gujarat. A WHO GMP & an ISO 10002: 2014, 9001: 2015 certified pharmaceutical company, --- Parenterals Ltd has traversed a long way in order to be recognized as one of the fastest growing Pharmaceutical Companies in India today. Growing at a fast yet steady pace, the second-generation contract development & manufacturing organization.
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- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.