Sr. Executive/Executive-Regulatory Affairs

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Sr. Executive/Executive-Regulatory Affairs

work outline icon0 - 2 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Ananta Medicare Ltd

time outline iconSri Ganganagar, Rajasthan, India

Posted on 19-11-2024

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1 Vacancy

Description

  • Ensure compliance with local, regional, and international regulations for products and services.
  • Prepare and submit regulatory documents, such as product dossiers, for approvals to regulatory bodies.
  • Monitor changes in regulations and ensure the company's products meet evolving legal and regulatory requirements.
  • Advise management on regulatory requirements, risks, and potential impacts on product development or marketing.
  • Develop and maintain relationships with regulatory agencies, ensuring effective communication and cooperation.
  • Coordinate with internal teams (e.g., R&D, legal, marketing) to ensure products are compliant from development to market launch.
  • Review and approve labeling, packaging, and promotional materials to ensure compliance with regulatory standards.
  • Lead the preparation for audits and inspections from regulatory agencies, ensuring compliance documentation is complete.
  • Ensure timely submission of renewals, variations, and amendments for product registrations.
  • Prepare regulatory reports and presentations for senior management, ensuring awareness of compliance status and issues.

Category

Pharmaceuticals

Preferred Education

MPharm (Master Of Pharmacy)BPharm (Bachelor Of Pharmacy)

Key Skills

CommunicationAttention to DetailProblem solvingPositive Attitude

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