Our client is a well reputed API/ Pharma Co. with one of its plant located at Nashik.
Post : Deputy. Manager-Regulatory Affairs (US/ EU markets)
Job Profile:
- Review and submission of DMF for US, EU & Japan, Submission of Certificate of Suitability (CEPs) dossier for EDQM, DMFs for Health Canada and Updates.
- Handling deficiencies raised by FDA during the course of reviewing of the USDMFs as well as deficiencies raised by EUs during the course of reviewing of the EDMFs under Centralized (CP), Decentralized (DCPs), Mutual Recognition Procedures (MRP) and National Procedures.
- Regulatory Compliance across the manufacturing site.
- Handling of Change Controls for their impact on respective regulatory submission.
- Interaction with Global customers regarding various Regulatory issues related to submission of Applicant’s Part of Active Substance Master Files [ASMFs] under MAA.
- Evaluation of starting materials for their adequacy with respect to Regulatory submission.
- Handling of questionnaires of various customers & regulatory authorities.
- Review and evaluation of Stability data for regulatory submissions.
- Preparation and review of SOPs related to Regulatory Affairs.
- Handling of eCTD software and other e-Platform for submission of Regulatory Documents in various agencies.
- Involvement in CMC documentation for preparing and updating the DMFs, CTDs of APIs as per USFDA,EDQM & Healthcare, TGA, KFDA, MHLW-Japan and other regulatory requirements.
Candidate Profile
1) M.Pharm or MSc Chem with 8 to 10 years experience in regulatory affairs (API).
2) Male Candidates preferred.
3) Ready to relocate to Nashik, Maharashtra.
Key Skills: DMF submission, CTD, regulatory affairs, API, EDMF, nashik, RA, M.Pharm, MSc Chemistry, EU submission, US submission, dindori
Salary Range: Rs. 8 to 10 lacs per annum (based on knowledge & experience)
Additional Information:
Education: M.Pharm, M.Sc
Experience: 8 to 10 years
Location: Nashik, Maharashtra
Industry: Pharma/Biotech
Salary Range: Rs. 8 to 10 lacs per annum
Last Date: 16th November, 2017
If the position interests you, kindly write to us along with your CV at aspsol.recruitments@gmail.com, also mention your current/expected CTC, notice period
Posted by
Reema Nambiar
Aspiring-Solutions
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