Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over US$ 4.5 billion. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than 100 countries across the globe
Job description
Regulatory Affairs – API
- Qualification: M.Sc-Chemistry
- Grade: Executive
- Experience: 2 – 4 years
Regulatory Affairs – Formulation – US (eCTD)
- Qualification: B.Sc/B.Pharm
- Grade: Sr. Officer / Executive
- Experience: 1-6 years
- Brief Job Description: 1) Regulatory submission/publishing activities for eCTD global submission dossiers according to Agency and ICH Guidance requirements. (US and other advanced markets). 2) Electronic Document Publishing (i.e. PDF file preparation as per eCTD requirement, bookmarking/linking, compilation/publishing in software.
Regulatory Affairs – Formulation – US
- Qualification: M.Pharm
- Grade: Executive / Sr. Executive
- Experience: 3 – 6 years
- Brief Job Description: 1) Review all data and documents related to product registrations for various health authorities. 2) Compile registration dossiers for submission to various health authorities like – US-FDA, Health Canada, Europe, Australia/New Zealand, Japan and Israel. 3) Prepare responses to deficiency letters received from various agencies. 4)) Maintain life-cycle / post approval changes for drug product registration dossiers. 5) Provide regulatory support to cross functional departments. 6) eCTD compilation, verification and submission through electronic gateway
Regulatory Affairs – Formulation – US (Labeling)
- Qualification: B.Sc/B.Pharm/M.Pharm
- Grade: Sr. Officer / Executive
- Experience: 1-6 years
- Brief Job Description: 1. Original Application submission : Labeling development for original applications (NDA/ANDA) in accordance with RLD labeling, current FDA guidance (s) and carve‐outs based on patents and exclusivity claims 2. Labeling Query responses and Patent Amendments : Thorough review/interpretation of FDA comments. Review of revised labeling and response. Tracking/ Review for Completeness/ Timely Submission. Review of patent amendment 3) Life Cycle Management : Track RLD labeling changes. Initiate labeling revision activity as per RLD label revision/safety labeling change ﴾SLC﴿ notification from FDA
Date : Sunday, 3rd December 2023,
Time : 9.30 am – 1.00 pm
Venue : Sun Pharmaceutical Industries Ltd – Sun Pharma Road, Tandalja – Baroda – 390016
Note : Candidates are requested to walk in with updated resume, last degree, PAN card, Aadhar card and current CTC proof at the venue.
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