Regulatory Affairs
SP Accure Labs Pvt Ltd
Hyderabad, Telangana, India
Posted on 13-05-2025
1 Vacancy
Description
- Prepare, compile, and review CTD/eCTD/ACTD dossiers for product registration in domestic and international markets
- Ensure timely submission of applications for new product approvals, renewals, and variations
- Coordinate with R&D, QA, QC, and manufacturing teams for technical documentation and data
- Respond to queries and deficiency letters from regulatory authorities
- Maintain up-to-date knowledge of current regulations, guidelines, and procedures
- Monitor regulatory status of products and ensure compliance with labeling and packaging regulations
- Handle post-approval changes, renewals, and periodic updates as per market-specific requirements
- Track registration status and manage regulatory databases and documentation systems
- Ensure that promotional and packaging materials comply with regulatory norms
- Participate in internal and external audits related to regulatory documentation
Category
Pharmaceuticals
Functional Area
Regulatory Affairs / Pharmacovigilance
Key Skills
Attention to DetailCommunicationTeam WorkPositive Attitude
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