Posted Nov 15, 2024 412 views
Regulatory Documentation Management
- Prepare, review, and submit regulatory documents for product registrations and variations.
- Ensure documentation accuracy and compliance with regulatory standards.
- Coordination with Regulatory Authorities
- Communicate effectively with regulatory authorities, including DRAP, to facilitate approvals and address queries.
- Stay updated on regulatory changes affecting the industry.
Post-Registration Activities
- Manage post-registration variations and address deficiencies.
- Ensure timely responses to regulatory letters.
Interdepartmental Collaboration
- Collaborate with various departments within DRAP and the company.
- Ensure smooth communication and regulatory compliance.
- Central Research Fund (CRF) Coordination
- Coordinate the CRF approval process with DRAP.
- Implement strategies to expedite CRF approvals.
Compliance Oversight
- Ensure all regulatory activities align with current requirements.
- Monitor and maintain regulatory compliance processes.
Technical Skills
Proficiency in DRAP portal operations.
Strong Microsoft Office skills, including Excel and Word.
Job Details
Welmark Pharmaceuticals
Welmark Pharmaceuticals is an ISO 9001:2015 & 14001:2004 certified manufacturing plant in compliance with the requirements of Current Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) and Goods Storage Practices (GSP) to ensure the implementation of Zero Defect Concept. The plant is equipped to provide a healthy, safe and conducive working environment to employees. Welmark brand & product portfolio contains over a hundred offerings quality as per cGMP. The aim of such a wide portfolio in the form of Tablets, capsules, sachets, suspensions and injectable is to satisfy our current & future customers, enabling more people to take charge of their health, meeting their often complex needs. Our ultimate goal is to provide better choices, better health for better lives.
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