Sr./ Executive Jobs in Nasik - Aspiring-Solutions
Job Description
- We have an urgent requirement for the post of Sr./Executive/ Officer -Regulatory Affairs with a well reputed API Mfg Co. for their plant at Nashik.
- Sr./ Executive Regulatory Affairs: 5-6 years exp into API RA - EU & US submissions), CTC around 3 to 6 lacs per annum
- Company Name: Well reputed API Mfg Co.
- Requirement: 5 Nos.
- Job Location: Nashik, Maharashtra
- Education: MSc (Chemistry), M.Pharm, B.Pharm
- Industry: API/ Pharma/ Biotech
- Function Area: Regulatory Affairs
- Key Skills: DMF submission, CTD, regulatory affairs, API, EDMF, nashik, RA, EU, US, MSc Chemistry, M.Pharm, fresher, dindori
- Salary Range: Based on knowledge & experience
- Preparation along with skills in reviewing and compliance checking (in eCTD format) API DMFs/CEPs intended to register in US & EU markets.
- Co-ordination and follow up with F&D, ADL, Manufacturing, Packing, QC, QA, TT team for getting all the necessary documents as per CTD requirement.
- Review of all technical data to ensure document compliance and to reduce quality error.
- Thorough knowledge in US, EU regions DMF submission procedures § Data Compilation & DMF preparation for US-FDA as per eCTD format.
- Checking & review of technical documents like AMV, PV, BMR, BPR, DMF, Finished product & API raw data, FPS/STP, COA, legal documents like COPP, FSC, Medical documents & SmPC (Summary Product Characteristics) etc.
- Responsible for handling change control.
- Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities
- Should have knowledge and experience in eCTD submissions to US and EU and troubleshooting the issues
- Thorough review of regulatory submissions prepared by team members and to ensure the correctness of the documents or submissions.
- Responsible for ensuring and sending response to all the technical queries received from various customers are properly responded as soon as possible.
- Responsible for ensuring that the regulatory database is properly maintained and updated.
- Responsible for Review and approval of change control and should ensure that all the approved changes are reported to regulatory authorities.
- Experience in regulatory affairs of API industry would be an added advantage.
- B.Pharm, M.Pharm or MSc Chem with relevant years experience in regulatory affairs (API).
- Male Candidates preferred.
- Ready to relocate to Nashik, Maharashtra.
Job Particulars
Role others
Who can apply Experienced (3+ Years)
Hiring Process Face to Face Interview, Telephonic Interview
Employment TypeFull Time
Job Id349307
Job Category Others
Locality Address
State Maharashtra
Country India
About Company
Our client is a well known name in the API/ Bulk Drug/ Pharma Industry
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