Naari Pharma Pvt Ltd. | Regulatory Affairs Specialist | gurugram
7 days ago
Who You Are:
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
- Manage the full life cycle of regulatory submissions for ROW markets, including initial submissions, query responses, variations, renewals, and post-approval maintenance.
- Independently prepare, compile, and submit high-quality regulatory dossiers that meet country-specific requirements.
- Address regulatory queries swiftly and accurately, ensuring timely communication and resolution without delays.
- Stay current with changes in regulatory policies, guidelines, and processes, applying this knowledge to product life cycle management.
- 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.
- Conduct risk assessments on regulatory strategies, identifying potential challenges and implementing proactive mitigation plans.
- Provide regulatory insights during new product development to ensure compliance with market-specific requirements.
- Review technical data and work with cross-functional teams to ensure alignment with updated regulatory requirements.
- 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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gurugram, India Naari Pharma Pvt Ltd. Full timeWho You Are: 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 Manage the full life cycle of regulatory...
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gurugram, India Naari Pharma Pvt Ltd. Full timeWho You Are: 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 Manage the full life cycle of regulatory...
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Gurugram, India Naari Pharma Pvt Ltd. Full timeWho You Are: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 ContributeManage the full life cycle of regulatory submissions for...
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Gurugram, India Naari Pharma Pvt Ltd. Full timeWho You Are: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 ContributeManage the full life cycle of regulatory submissions for...
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