BriefCase
BriefCase

Asst. General Manager Or General Manger Job in Accelius Global

Asst. General Manager Or General Manger

Accelius Global 4+ weeks ago
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Job Summary
  • Achieve timely submission of dossier deficiency responses to regulatory authority by reviewing, collating, and compiling documents in order to ensure approvals for launch in stipulated time
  • Submit post approval variations for changes that improves productivity, cost-effectiveness, quality of the product by reviewing, collating, compiling the variation application to meet the delivery within timelines and maintain Product Marketing Authorization, Renewals to ensure continuous validity of marketing authorizations.
  • Maintain, and update product dossier as required to meet changes in internal systems, changes in regulatory guidelines, and to meet the need of regulatory requirements.
  • Update the database associated with product dossier approvals by including registration details in database.
  • Provide Regulatory support throughout the life cycle of the product for smooth functioning.
  • Check with regulatory authorities for submission activity and approval status for submission done.
  • Coordination with internal and external stakeholders for regulatory filing related documentation.
  • Review, compilation and authoring of as per regulatory requirements.
  • Review of plant and R&D documentation such as development reports, BMR, BPR, Specifications, method validation, process validation etc.
  • Consulting, categorizing, authoring Post approval changes through appropriate supplements.
  • Provide responses to regulatory agencies regarding product information or issues.
  • Train staff in regulatory policies or procedures.
  • Develop and maintain standard operating procedures or local working practices.
  • Establish regulatory priorities or budgets and allocate resources and workloads.
  • Establish regulatory priorities or budgets and allocate resources and workloads.

Qualification :
BPharm / MPharm
Experience Required :

Minimum 15 Years

Vacancy :

2 - 4 Hires

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