Regulatory Affairs Specialist
2 weeks ago
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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