Regulatory Affairs Specialist

2 weeks ago


Mumbai, Maharashtra, India DigiFocal IT Solutions Pvt Ltd Full time

Senior Regulatory Affairs Executive

Location: Dadar

Years of Experience: 10+

Mandatory Requirements: Candidates from Pharmaceutical Companies with Formulation experience.

Key Responsibilities:

  • Regulatory Expertise: Manage the regulatory process for Pharmaceutical Finished Formulations across CIS, LATAM, and Africa.
  • Dossier Management: Compile and review ACTD and CTD dossiers to ensure accuracy and compliance.
  • MOH Query Response: Address and respond to any Ministry of Health (MOH) queries for dossiers submitted in the relevant territories.
  • Compliance: Review product artworks and samples to ensure compliance with regulatory requirements.
  • International Coordination: Liaise with international agents for dossier submission, follow-up, and product registration.
  • Documentation: Maintain comprehensive records of technical documentation, product registrations, and related expenses.
  • Team Management: Lead and manage the regulatory affairs team, ensuring deadlines and regulatory goals are met.

Requirements:

  • Proven Expertise: Regulatory field of pharmaceutical finished formulations for CIS, LATAM, and African markets.
  • Experience: Compiling and reviewing ACTD and CTD dossiers.
  • Proficiency: Handling MOH queries and ensuring timely responses.
  • Attention to Detail: Checking product artwork and samples for regulatory compliance.
  • Coordination Skills: International agents and managing dossier submission and registration processes.
  • Organizational Skills: Maintaining technical documentation and tracking expenses.
  • Team Leadership: Managing the regulatory affairs team.


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