Full-Time, Remote
Mumbai
Posted 4 days ago

Roles and Responsibilities

  • Compilation, Preparation, review & submission of dossiers as per Standard guidelines for product registration for export, renewal & variation applications submission for registration.
  • Ensure accuracy, completeness & quality of regulatory submission.
  • Handling FDA requirements
  • Ensure all product artworks are updated when necessary requirement & approved to submitted for registration.
  • Co-ordinate and follow-up with manufacturer for documents & samples/WS required for regulatory submission.
  • Collaborate with Export Manager in Business Development activities.
  • Responding to queries pertaining to regulatory submissions from various regulatory authorities.

Qualification

  • B. Pharm/M. Pharm/ M.sc
  • At least 3 to 5 years of experience in regulatory affairs for Export.
  • Should have strong command over writing & verbal communication in English/Good knowledge of ICH, WHO & semi regulated or regulated market.

Job Features

Job Category

Software Engineer

Industry

Pharmaceutical & Life Sciences

Functional Area

Legal & Regulatory

Role Category

Corporate Affairs

Employment Type

Full Time, Remote

Education

B.Sc in Any Specialization, B.Pharma in Any Specialization, M. Pharm

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