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. Please find the details below:
- Sr./ Executive Regulatory Affairs: 5-6 years exp into API RA – EU & US submissions), CTC around 3 to 6 lacs per annum
- Sr. Officer/ Executive Regulatory Affairs: 3-4 years exp into API RA – EU & US submissions), CTC around 2 to 3 lacs per annum
- Officer Regulatory Affairs: Fresher, MSc Chemistry or B.Pharm with good communication skills, CTC: as per industry stds.
Company Name: Well reputed API Mfg Co.
Requirement: 1 Nos.
Job Location: Nashik, Maharashtra
Education: MSc (Chemistry), M.Pharm, B.Pharm
Experience: 0-6 yrs in API Mfg Co.
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
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 & DMFpreparation for US-FDA as per eCTD
- 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 RegulatoryOperations 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.
If the position interests you, kindly write to us along with your CV at firstname.lastname@example.org, also mention your current/expected CTC, notice period
Please mention the name of the post as an email header you wish to apply for.