Website Adaptis Pharma
About Adaptis:
At Adaptis, we deliver comprehensive consulting solutions that empower healthcare companies to navigate complex regulatory landscapes and succeed in global markets. With expertise in pharmacovigilance and regulatory affairs, we help drive compliance, innovation, and growth.
🚀 Position: Senior Executive II – Drug Product Regulatory Affairs
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Experience Required: 4–6 years
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Location: Pune
Key Responsibilities:
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Preparation of ANDA sections for injectable/ophthalmic dosage forms in compliance with regulatory guidelines.
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Review and filing of query responses, annual reports, and supplements for approved injectable/ophthalmic products for the US market.
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Review of CMC documents and development reports as per regulatory requirements.
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Efficient coordination with stakeholders to gather and manage relevant documentation.
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Stay abreast of updates in US regulatory legislation and guidelines.
🩺 Position: Senior Executive I – Medical Device Regulatory Affairs
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Experience Required: 3–5 years
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Location: Pune
Key Responsibilities:
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Review documentation for medical device submissions in the USA/EU regions.
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Preparation and writing of 510(k) application sections.
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Compilation of 510(k) dossiers as per specific regulatory authority requirements.
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Offer guidance to client teams regarding medical device compliance.
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Track and interpret global regulatory updates relevant to medical devices.
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Support in responding to regulatory queries during application reviews.
📍 Job Location:
Pune, Maharashtra, India
📧 How to Apply:
Send your updated resume to: Info@adaptisls.com
Last Date to Apply: 15th August 2025
Join Us
If you’re passionate about regulatory strategy and ready to make a global impact in healthcare, Adaptis welcomes your expertise!
Adaptis is an equal opportunity employer. We value diversity and are committed to building an inclusive environment for all employees.
To apply for this job email your details to Info@adaptisls.com