Regulatory Affairs - Executive
Job Description:
Key Responsibilities:
Prepare, compile, and submit CTD/eCTD dossiers for EMA and DGMED (France) including new registrations, renewals, and variations.
Coordinate with internal teams (QA, QC, R&D, Supply Chain) for document collection and compliance.
Liaise with regulatory agencies and local representatives in the EU and France for query resolution and approvals.
Ensure dossiers and product documentation (SmPC, PIL, labels) meet EU and French regulatory requirements.
Maintain submission trackers and stay updated on relevant EU/DGMED guidelines.
Requirements:
Degree in Pharmacy, Life Sciences, or related field.
3–7 years of regulatory affairs experience with direct EMA and/or DGMED submissions.
Strong knowledge of EU regulations, CTD/eCTD format, and regulatory processes.
Good communication and coordination skills with attention to detail.
Key Skills :
Company Profile
Our client followa standards of WHO - CGMP
Our Mission
“To become a valued Pharmaceutical partner to the World Pharma fraternity by continuously researching, developing and manufacturing a wide range of pharmaceutical products that complies with the global regulatory standards.”
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- Interested candidates are requested to apply for this job.
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