Manager - Regulatory Affairs

Posted On 14th May, 2022

Designation : Manager - Regulatory Affairs

Role : Head - Regulatory Affairs

Functional Area : Regulatory Affairs

Education : BSc, / MSc - Chemistry, BE - Chemical / Biotech

Industry Type : API

Experience : 8 -15 Years

Compensation : Negotiable

Location : Limbasi

Job Description
  • Working knowledge of US, EU, Brazil, Japan, Russia, Korea & Row Market.
  • Preparing Dossiers for registration of products in various markets.
  • DMF Preparation, review and submission according to latest requirements.
  • Knowledge in regulatory affairs, eCTD and regulatory guidance.
  • Filing of amendments & lifecycle management as per requirement.
  • Co-ordination with cross functional departments for documents required for regulatory submission.
  • Post approval changes and its filing & deficiency responses to various regulatory authorities.
  • Good understanding of regulatory regulations, standards and guidance documents.
  • Review, compilation and submission of new marketing authorization application.
  • Review of DMF & pharmaceutical development reports for regulatory submissions.

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