Vacancy for Regulatory Affairs Executive at Gracure Pharmaceutical Ltd | M.Pharm, B.Pharm
Gracure Pharmaceutical Ltd. is a Delhi based pharmaceutical company, established in 1992 by Mr. A.S Bhargava with the vision of making world class affordable medicines. Gracure is a research driven forward looking pharmaceutical company with expertise in development of various finished dosage. Gracure R&D and EU-GMP approved Manufacturing Unit is located in Bhiwadi, Rajasthan.
Post : Executive Regulatory Affairs (Emerging markets APAC, FWA, Latam)
- Collaboration with internal stakeholders (manufacturing , R&D, stability) to compile quality dossiers timely, as per country specific requirements.
- Review of CMC documents for submission viz. API DMF,BMR, Specifications/STP, Method validation reports, stability, process validation data etc.
- Follow up with stakeholders to get corrected documents in line with review comments.
- Dossier writing with focus on accuracy and adequacy of data.
- Preparation and review of responses to queries timely.
- Preparation and review of Variations and renewals as per country specific requirements.
- M. Pharm(QA/ Pharmaceutics/pharm Chem) or B.Pharm with good percentile.
- Maintain good communication and collaboration with team and seniors.
- Good written/ spoken English.
Additional Information :
Experience : 2-5 Years
Qualification : B.Pharm, M.Pharm
Location : Delhi
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 10th August, 2020
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