Posted: 1 year ago
Posted: 1 year ago
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Job Description
JobResponsibilities:
- Dossier preparation/review as per country specific guideline/CTD guideline
- Timely query response submission to Distributor/ MOH
- Review of documents for its correctness and compliance with respective regulatory guidelines (as per country requirement)
- Preparation, review & release of artworks & sales order as per country approval
- Variation documents preparation and filing as per country requirements
- Timely dispatch of tender documents to country/parties as per deadline
Candidate profile
- Should be able to review & interpret the requirement as per country specific/ tender guideline/Query received from MOH
- Should be able to review various plant documents for dossier preparation like Process validation, Stability study, PDR, Method validation, SOP, Drug Master File, BMR, APR etc.
- Should be able to communicate with relevant functions for procurement of required regulatory documents
- Should be able to communicate with relevant business partner at country
Skills
CTDDossier SubmissionDossier PreparationRegulatory AffairsSubmissionRegulatoryDossierProcurementIf a job posting appears fraudulent, asks for payment, contains misleading information, or violates our guidelines, please report it immediately. Our team will review it promptly, Jobaaj does not charge any fee from the applicants.
About Company
Otsuka Pharmaceutical was established in 1964.
At Otsuka Pharmaceutical, we are committed to a holistic approach to health and well-being of people and are striving to create innovative, thoroughly-original pharmaceutical and nutraceutical products based on our corporate philosophy ""Otsuka-people creating new products for better health worldwide"".
With these two core businesses, analogous to riding on a bicycle, we drive on two wheels.
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