Regulatory Specialist

PeopleStrong HR Services Pvt. Ltd.
  • Mumbai
  • 10-15 lakh
  • 4-9 years
  • Views
  • 23 Feb 2017

  • Medical Services, R&D/ Research & Development

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Collaborating with commercial teams to ensure alignment on prioritisation of regulatory efforts
Securement and maintenance of market authorisations for all regulated markets within APAC; South East Asia
Liaising with Distributors, Affiliates, multiple companies sites and Regulatory agencies throughout the regulatory process
Compilation of submissions to country specific requirements
Maintainance of regulatory data applicable to APAC; South East Asia to ensure adequate visibility to the business and compliant release of product to regulated markets.
Assessment of change impact on existing market authorisations to support inventory planning
Maintaining their understanding of the regulatory frameworks within South East Asia and effective communication of changes which may have an impact on the business

Competencies/Skill sets for this job

Inventory Planning Maintenance Assessment

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