Regulatory Affairs

2 days ago

Rajkot, Gujarat, India Pramukh Staffing Full time ₹ 9,00,000 - ₹ 12,00,000 per year


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.


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