Officer Regulatory Affairs require in Zydus BSV Pharma
Zydus BSV Pharma Pvt. Ltd., founded in 2005 is a joint venture company of Zydus Cadila, a global healthcare company and Bharat Serums and Vaccines Limited (BSV), one of the top 10 biotech companies in India.
With a focus on niche segment of targeted therapies in the area of Oncology, Zydus BSV Pharma develops, manufactures and markets non-infringing and proprietary Novel Drug Delivery System (NDDS) of approved anti-cancer agents for global markets.
Post: Officer Regulatory Affairs
- Preparation and submission of dossier for international regulatory agencies as per various requirements according to regulations and guidelines of respective country.
- Review the requirements for manufacturing and registration of drug product to regulatory countries such as USA, UK, Australiya , South Africa, Brazil, and other semi regulated countries or as required by the organization.
- Review the following documents necessary for Dossier preparation and submission, Batch manufacturing and packing record specification, Method of analysis, certificate of analysis of raw material and finished product, Analytical method, Validation protocol and report, Performance qualification protocol and reports of critical processing equipments Stability study protocol and reports
- BET validation, Sterility Validation Container – Closure, Integrity protocol and reports.
- Thermal Cycling study, Photo stability study, Dilution study, In use study protocol and reports.
- Other documents as per the requirement of the regulatory agency
- Review the various pharmacopoeias changes and intimate for the change to organization.
- Review of change control and update the customer or regulatory bodies where required.
- Preparation and submission of various documents required for liasoning work such as test license application, product permission permission application and other approval required by the organization.
- Review of queries raised by regulatory authorities and to comply by providing the necessary documents.
- M.Pharm from reputed institute
- having experience of Regulatory, Good negotiation skill, excellent communication skill
Experience: 1-2 years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: DRA
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