Sr./ Executive Jobs in Nasik - Aspiring-Solutions

Sr./ Executive
3+ Years
200000 - 250000 Per Year
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.
  • 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 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

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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.
Aspiring-Solutions Company recruits a lot of Experienced(3+ Years) candidates candidates every year based on the skills . The candidates with M.Pharm, MSc are selected to full fill the vacancies in Others job field. The candidates nearby Nasik can apply for Sr./ Executive position in Aspiring-Solutions. All candidates should have a degree or post-graduation in the required field based on the requirement mentioned. The jobs are available in Full Time basis. When it comes to the Aspiring-Solutions recruitment, candidates are mostly chosen for the department of Others . To learn more about the current jobs and other details, it is better to go through official site of Aspiring-Solutions and Freshersworld. Find the latest jobs near you and near your home. So, that you don’t need to relocate. The Freshersworld is a leading employment portal that researches the official site of Aspiring-Solutions and provides all the details about the current vacancies, the application process, selection process, interview test details, important dates and other information. Search and apply for the top job positions in Aspiring-Solutions and near your city and get a secured career.