Manager/Asst. Manager-Regulatory Affairs

Manager/Asst. Manager-Regulatory Affairs

work outline icon2 - 6 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

CAD Pharma Inc.

time outline iconHyderabad, Telangana, India

Posted on 10-06-2025

1 Vacancy

Description

  • Regulatory Submissions: Prepares and compiles regulatory dossiers and submissions for product registrations, variations, and renewals for various markets.
  • Documentation Review: Reviews product development reports, manufacturing documents, and quality control data for regulatory compliance.
  • Guideline Interpretation: Interprets and applies regulatory guidelines and requirements relevant to the company's products and target markets.
  • Query Handling: Responds to queries and deficiencies from regulatory authorities in a timely and accurate manner.
  • Database Management: Maintains and updates regulatory databases and tracking systems for submission status and approvals.
  • Cross-functional Support: Collaborates with R&D, Production, Quality Assurance, and Marketing to ensure regulatory requirements are integrated into product development.
  • Compliance Monitoring: Monitors changes in global regulatory landscapes and assesses their impact on existing products and ongoing projects.

Category

Pharmaceuticals

Functional Area

Regulatory Affairs / Pharmacovigilance

Key Skills

Attention to DetailCommunicationTeam WorkProblem Solving

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