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Sr./ Executive Jobs in Nasik - Aspiring-Solutions

Sr./ Executive
Aspiring-Solutions
3+ Years
200000 - 250000 Per Year
Aspiring-Solutions
Last Date 10 Dec 2017

Aspiring-Solutions - Job Details

Date of posting: 11 Oct 17
  • 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
Job Profile: 
  • 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.
Requirements:
  • 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 Summary

Job Type : Full Time
Job Role : Others
Job Category : Others
Hiring Process : Face to Face Interview, Telephonic Interview
Who can apply : Experienced (3+ Years)

About Aspiring-Solutions

Our client is a well known name in the API/ Bulk Drug/ Pharma Industry
This posting is done directly & exclusively on Freshersworld.com. We do not entertain any unsolicited calls or enquiries from any consultants, other portals or TPOs. Notice: This recruitment is FREE. if the recruiter charges any fees, please write us info@freshersworld.com

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Aspiring-Solutions recruiting Sr./ Executive Experienced(3+ Years) candidates candidates nearby Nasik.Aspiring-Solutions vacancies for Sr./ Executive is recruited through Written-test, Face to Face Interview etc.
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