Regulatory Affairs (China Markets) For Pharma
- BVR People
- 5 to 8 Yrs
- Hyderabad
- 2 years ago
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Job Description
Roles and Responsibilities
Job Title: Regulatory Affairs (China Markets)
Company: Leading Pharma Company in Hyderabad Location
Designation: Sr. Executive to Assistant Manager
No. of Positions: 2
Division: Formulation OSD
Department: Regulatory Affairs
Location: Hyderabad Location
Qualification: M.Pharma
Years of Experience: 5 to 8 Years
Salary Range: 10 LPA
Contact person: Mr.Zabi Moghal
Mobile: 8105301***
Email: za*i@bv**c.com
Key Responsibilities:
- Preparation of Dossier by understanding the regulatory requirements and by communicating the requirements to CFT team. Listing the open points and ensuring the response be ready by the time we receive the deficiency.
- Preparation of BE NoC / CT NoC applications for submission to NMPA (formerly, CFDA).
- 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
- Preparation of GEA application and provide the appropriate information about the data to be generated at R&D / Manufacturing plant in support to the application
- Update the team on various reforms happens at NMPA 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 with various CFTs.
- Evaluating the changes in Life Cycle Management of the product 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 country team.
Key Personal Attributes:
- Good communication skills (written, oral, presentation)
- Excellent inter personnel skills, high level of proficiency in networking internally and externally
- Must be quick learner and should be able to prioritize tasks
- Awareness & understanding of cross-cultural sensitivity
Operating Network:
- Internal - DLT, PDT, China RA, Portfolio, QA, QC, SCM & Packaging Development team.
- External - External API manufacturers, Excipients and Packaging material suppliers. CRO, CMO, Development Partner s & Regulatory Authorities
Employement Category:
Employement Type: Full timeIndustry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Regulatory Affairs (China Markets) For Pharma
Contact Details:
Company: BVR People ConsultingLocation(s): Hyderabad
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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