Job Purpose To manage and coordinate product registration activities in domestic and international markets, ensuring timely preparation, submission, approval, renewal and maintenance of product registration dossiers in compliance with applicable regulatory requirements.
Roles & Responsibilities
- Manage current product registration activities in domestic and international markets.
- Prepare and compile product registration dossiers as per country-specific regulatory guidelines.
- Coordinate with regulatory authorities for product registration and approval.
- Maintain product registration status and approval records.
- Coordinate with overseas agents, distributors and consultants for registration activities.
- Documentation & Dossier Management
- Monitor regulatory guidelines and requirements of different countries.
- Ensure compliance with applicable pharmaceutical regulatory requirements.
- Coordinate for product renewals and registration extensions.
- Handle regulatory queries and deficiency letters.
- Coordinate with internal departments to provide responses to regulatory authorities.
- Track changes in regulatory requirements and communicate updates to concerned departments.
- Maintain records of registered, under-registration and discontinued products.
- Coordinate variations and amendments in approved products.
- Maintain country-wise product registration databases.
- Follow up with regulatory authorities and international agents.
- Prepare monthly registration status reports.
Required Skills
- Regulatory documentation and dossier preparation.
- Communication and coordination.
- Document control and record management.
- Analytical and problem-solving skills.
- Time management and follow-up.
- Ensure proper documentation and regulatory compliance.