Regulatory Affairs Specialist
2 weeks ago
You are skilled professional with deep understanding of regulatory frameworks and have a proven track record of managing the entire regulatory life cycle independently. Your ability to manage projects end-to-end makes you a valued contributor in achieving product approvals.
How You Contribute
1. Manage the full life cycle of regulatory submissions for ROW markets, including initial submissions, query responses, variations, renewals, and post-approval maintenance.2. Independently prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.3. Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.4. Stay current with changes in regulatory policies, guidelines, and processes, applying this knowledge to product life cycle management.5. Serve as the sole regulatory point of contact within cross-functional teams, collaborating with R&D, Quality, and Manufacturing to align regulatory strategies with business goals.6. Conduct risk assessments on regulatory strategies, identifying potential challenges and implementing proactive mitigation plans.7. Provide regulatory insights during new product development to ensure compliance with market-specific requirements.8. Review technical data and work with cross-functional teams to ensure alignment with updated regulatory requirements.9. Maintain accurate and comprehensive documentation of regulatory activities for audits and future reviews.
What You Bring to the Team
- M. Pharma with 5-9 years of relevant experience in Regulatory Affairs, focusing on ROW markets- In-depth knowledge of regulatory submission processes and life cycle management- Strong expertise in responding to complex regulatory queries and handling post-approval changes.- A proactive, detail-oriented approach with the ability to independently manage multiple projects and deadlines.- Excellent written and verbal communication skills- Knowledge of ICH guidelines, ROW-specific regulatory pathways
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