Watson Pharma Private Limited jobs - Regulatory Affairs Associate I

Regulatory Affairs Associate I

Watson Pharma Private Limited

Mumbai

0 to3 Years

Salary not disclosed

B.Pharm, M.Pham, BSc, MSc, Other Course

Job Description

Roles Responsibilities

Change control assessments for EU other international markets Completing initial RA assessment in GCCM trackwise

Creating regulatory submission task

Coordinating with Canada site RA cross functional team and submission RA and finalization of change classification

Compilation of variation package and providing to submission RA

Compilation of US Annual report package for Canada site Intimating to the respective sites for supporting documents after receipt of day 0 mail

Reviewing the documents

Preparing of tracked changes copy of index from previous annual report Finalizing the AR package and dispatching to submission RA within 30 days of receipt

Preperation and submission of ANDA product monograph update to health canada

Updating the product monograph for canadian products as per the canadian reference product within 30 working days

Qualifications 36 years of relevant experience with MSC BSC M Pharm B Pharm as an education Function Regulatory Affairs Sub Function Medical Regulatory Affairs

Job Particulars

Role

Education B.Pharm, M.Pham, BSc, MSc, Other Course

Who can apply Freshers and Experienced (0 to3 Years )

Hiring Process Face to Face Interview

Employment Type Apprenticeship

Job Id 960513

Job Category Pharma , BSc/BCA/BBM

State Maharashtra

Country India

About Company

Watson Pharma Private Limited

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Hyderabad

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