Senior Regulatory Affairs Executive - kandigai , Chennai

ROLES AND RESPONSIBILITIES:

1. Regulatory Submission Preparation: Must have compiled and filed comprehensive regulatory submissions to health authorities such as USFDA, EU, UK, CANADA, AUSTRALIA, GCC, LATAM and others. Familiarity and experience with Type I, Type II variations, DCP/National/MRP route. Should have proven track record for no-RTR.

2. Strategic Advice: Providing strategic regulatory input to cross-functional teams during product development, product lifecycle management and market access strategies.

3. Data Review and Analysis: Evaluating CMC for solid dosage forms such as Tablets and Capsules, bioequivalence studies and other scientific information to support regulatory submissions.

4. Labelling and Packaging Review: Reviewing product labelling and packaging to ensure accuracy and compliance with regulatory requirements.

5. Regulatory Agency Interactions: Communicating with regulatory authorities to address queries (IR, DRL, CRL), respond to inspections, and negotiate approval pathways.

6. Post-Marketing Surveillance and Compliance Monitoring: Monitoring marketed products for safety concerns and reporting adverse events to regulatory agencies. Staying updated on evolving regulatory guidelines and ensuring company practices adhere to them including audit readiness.

7. Regulatory Intelligence: Tracking legislative changes and emerging regulatory trends to proactively identify potential impacts on the company's products.

DESIRED CANDIDATE PROFILE:

• Minimum 3 - 7 years experience in regulatory affairs department for SRA markets.
• Experience in dossier filing for SRA markets.
• Deep understanding of relevant regulations and guidelines (e.g., FDA, EMA, ICH)
• Strong scientific background in pharmacology, clinical research, and drug development
• Excellent writing and communication skills to prepare clear and concise regulatory documents
• Analytical skills to interpret complex data and assess regulatory risks
• Exposure in CMC for dossier preparation for Tablets and Capsules products.
• Project management skills to manage multiple regulatory submissions and timelines
• Ability to collaborate effectively with cross-functional teams including R&D, QA, QC, and Production.