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Regulatory Affairs Associate I - Mumbai @ Watson Pharma

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 Regulatory Affairs Associate I - Mumbai

Job Description

Job Description
  • They will be responsible for Metrics and Reporting mainly for EU, but ad hoc Globally and for supporting GRA Compliance.
  • Work with other members of staff for reporting EU Gx & Specialties metrics.
  • Provide ad hoc global or regional reports, as required
  • GRAP/AQUA data entry
  • Retrieval and analysis of data from GRAP and AQUA
  • EU submission fee calculations
  • Assist with managing GRA s procedures and learning systems for SOPs & Work Instructions, including processing through established DMS and LMS and monitoring of periodic reviews.
  • The candidate will be expected to work within GRA, liaising with other business units (eg R&D, portfolio, RA etc) to ensure that all data is compliant.
  • They need to be familiar with the IT systems the company uses in order to retrieve the data efficiently and accurately.
Qualifications
1-2 Yrs MSc or BPharm with e xposure to Metrics and Reporting mainly for EU

Job Classification

Industry: Pharma, Biotech, Clinical Research
Functional Area: Medical, Healthcare, R&D, Pharmaceuticals, Biotechnology,
Role Category: Drug Regulatory Affairs/Documentation
Role: Drug Regulatory Affairs/Documentation
Employement Type: Full time

Education

Under Graduation: B.Pharma in Pharmacy
Post Graduation: MS/M.Sc(Science) in Chemistry
Doctorate: Doctorate Not Required, Any Doctorate in Any Specialization

Contact Details:

Company: Watson Pharma
Location(s): Mumbai

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Keyskills:   LMS Regulatory Affairs Associate Networking Pharma HR Dms Management Regulatory affairs Monitoring Data entry

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Watson Pharma

Watson Pharmaceuticals, Inc. (NYSE-WPI) is a global specialty pharmaceutical company with approximately $3 billion in revenues, a broad product line and operations in well-established and emerging markets.