Medley Pharmaceuticals LtdRecruitment August 2020. Medley Pharmaceuticals Limited operates as a pharmaceutical company. The Company manufactures pharmaceutical formulations such as hematinics, anti bacterials, gynecology, cardiovascular, and other related drugs.
Important Vacancy details:
- Post Name: Assistant Manager -Regulatory Affairs
- Education :B.pharma,B.sc,M.sc,M.pharma
- Experienced:05 to 10 years
- Location: Daman & Diu
- Salary : NA
- Openings :NA
- Recruiter Name:Keval Patel
Job Description: We have requirement for the post of Assistant Manager -Regulatory Affairs in Medley Pharmaceuticals Ltd !
- Coordination and review for administrative data required for dossier submission.
- Coordination with Production, Store, QC and R&D for archival of regulatory samples, packing component, Working standard & analytical data
- Monitoring of New Material Introduction and New Product Introduction activities for ANDA & EU Dossiers.
- To prepare requirement for FDA applications related to FSC, COPP, additional product license, tender documents etc.
- To maintain license documents and other FDA documents.
- Review and Co-ordination for the Gap Analysis for the Regulatory News Letters and follow ups for the closures of identified actions.
- Coordination, tracking and follow up with production and IPQA concerned for Sample requirement for various countries.
- Providing registration details along with registration certificates to plant concerns in coordination with RA-HO.
- Review and issuance of Registration compile status and respective addendum to all plant concerns within stipulated period.
- Reviewing and approval of product conversion form for different country based on need of International business in coordination with Regulatory Affairs –HO.
- Reviewing and approval of BMR, BPR on behalf of Regulatory affairs.
Selection Process: The selection will be on the basis of Interview.
How to Apply : Click here for full details and Apply Online