Regulatory Affairs Manager

Regulatory Affairs Manager

work outline iconFresherrupess outline iconNot disclosed time outline iconFull Time

SP Accure Labs Pvt Ltd

time outline iconHyderabad, Telangana, India

Posted on 01-04-2025

1 Vacancy

Description

  • Managing regulatory submissions and approvals for new and existing products.
  • Liaising with regulatory authorities to ensure compliance with local and international laws.
  • Preparing and reviewing documentation for regulatory submissions.
  • Analyzing and interpreting regulatory requirements and changes.
  • Developing and implementing regulatory strategies for market entry and product lifecycle management.
  • Providing guidance on labeling, advertising, and promotional materials to meet regulatory standards.
  • Conducting risk assessments and ensuring compliance with safety standards.
  • Coordinating with cross-functional teams to ensure regulatory requirements are met in product development.
  • Keeping up to date with regulatory changes in the industry.
  • Maintaining detailed records of regulatory filings and correspondence.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Good CommunicationAttention to DetailDecision Making SkillsTeamwork

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