Rusan Pharma Ltd Released Job Openings On 15/04/2022.Rusan is a research driven pharmaceutical company having its Manufacturing Units in India and Worldwide Marketing of Pharmaceutical Formulation, Active Pharmaceutical Ingredients and Intermediates. The company has its own Research & Development centre at Kandivli (west), Mumbai, state of the art, Bulk Manufacturing Plant at Ankleshwar and Formulation plant at Dehradun and SEZ, Kandla having approval of MHRA (UK), MCC (SA) and other International Health Authorities.
Vacancy Details:
Rusan Pharma Ltd Recruiting Candidates with 1+ years of Experience for Regulatory Affairs Department.Complete Details for the Regulatory Affairs as follows.
Important Details :
- Location : Mumbai
- Countries: Australia / New Zealand/ Canada/ Brazil /Mexico/ CIS countries/ Europe/UK
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application: 15/04/2022
- Mode of application :Online
- Email Id: Interested candidates can share their profile at shalini.singh@rusanpharma.com
- Time and Venue : 16th April, 2022,10.00 AM – 5.00 PM,Rusan Pharma Ltd.58-D, Government Industrial Estate, Charkop, Kandivli (W),
Mumbai – 400 067,Board Line: 022 42383000 / 42383063
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Job Description/Skills Required
1. Responsible for Dossier compilation:
- To prepare new, renewal dossier (Semi Finished/ Finished Product) and variations (Site/ Formula) of South Asia, LATAM countries and having specific knowledge for South Africa and Brazil filing and Regulatory knowledge of Guidelines viz, ICH , FDA PICs etc.
- To review accuracy of executed data before submission – Plant generated validation reports and raw data as required to ensure compliance before Dossier submission.
- To review of documents for adequacy and accuracy.
- To ensure regulatory compliance and liaison with countries / regulatory authorities during the product registration process.
- To arrange the samples as per country requirements.
2. Responsible for Tender compilation:
- To gather, evaluate, organize, manage and collate information/ documents requirements for Tender fillings for WHO.
3. Ensure timely delivery of regulatory query:
- To review and ensure accuracy of deficiency response for Quality, Clinical part of dossier.
- To evaluate the query received for registered or under registration products and Tender products and also to support for completion of the same in timely manner.
4. Compliance (Audits / Audit Readiness)
- Support in Site Audit Readiness and Compliance relevant to RA functions / procedures based on external / internal audits.
Desired Candidate Profile:
Candidate must have prior experience in dossier preparations, review and submission for Australia / New Zealand/ Canada/ Brazil /Mexico/ CIS countries/ Europe/UK.
