Largest Pharma company looking - Regulatory
- BVR People
- 2 to 7 Yrs
- Hyderabad
- 4 years ago
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Job Description
Dear Professionals!!Greetings! Department : - Regulatory Affairs (China market). Formulations (OSD / Injectable) Qualification :- M.Pharma/ MSc Experiences :- 2 to 7 years Location:- Hyderabad Region: China (Must) Responsibilities: Candidate should have strong experience in China market Guidelines. Key Responsibilities: Involve in the product selection by understanding the regulatory requirements. To facilitate the smooth dossier preparation, by understanding the regulatory requirements and by communicating the requirements to team. Listing the open points and ensuring the response be ready by the time we receive the deficiency. Evaluating the product suitability for tech transfer in China CMO's and reviewing the various plant documents, coordinating with china team for dossier preparation. Coordinate for PQC testing. Understand the PQC deficiency and coordinate with internal team to get the required information for the response. BE NOC application submissions with China FDA. Preparation of GEA application and provide the appropriate information about the data to be generated at R&D / Mfg. pant in support to the application. Update the team on various reforms happens at CFDA and evaluate the impact on existing products/products under evaluation/products planned in near future. Understanding the deficiency and preparation of deficiency response by coordinating Internal regulatory team. Evaluating the changes in life cycle management of the product for commercial products and providing the inputs for variation application requirements. Coordinating with the commercial team and identifying the right time for variation filing to ensure that the supplies would not get disturbed. Coordination with packaging development team to Organize the artworks review and approval process with China team. If you are looking for world class company kindly revert with your Updated CV along with below details to sa****a@bv**c.com CTC ECTC Notice period Reason for Change Family willingness to move Hyderabad.Salary: Not Disclosed by Recruiter
Industry: Pharma / Biotech / Clinical Research
Functional Area: Medical , Healthcare , R&D , Pharmaceuticals , Biotechnology
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Director
Employment Type: Full Time, Permanent
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PG - MS/M.Sc(Science) - Any Specialization, M.Pharma - Pharmacy
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Largest Pharma company looking - Regulatory
Contact Details:
Company: BVR People ConsultingLocation(s): Hyderabad
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BVR People
Company ProfileBVR People ConsultingBVR people consulting committed to help Organisations to realise and develop their full potential in order to compete in the present day globalised and technology driven business environment. BVRPC invigorates the key components of organizations - The People and...
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