Manager/Asst. Manager-Regulatory Affairs
CAD Pharma Inc.
Hyderabad, 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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