{"@context":"https://schema.org","@type":"JobPosting","title":"Assistant Manager To Manager-RA OSD(UK Markets)Mumbai","description":"

Role & responsibilities

Prepare, compile, review, and submit regulatory dossiers for UK MHRA and European markets.
Handle new Marketing Authorization Applications (MAA), dossier variations, renewals, line extensions, and responses to deficiency queries.
Prepare and review CTD/eCTD dossiers in compliance with regulatory requirements.
Coordinate with cross-functional teams including R&D, Formulation Development, Analytical Development, QA, QC, Manufacturing, Packaging Development, and Supply Chain to obtain regulatory documentation.
Monitor regulatory changes and ensure submissions remain compliant with current UK MHRA and EU guidelines.
Review labeling, artwork, SmPC, PIL, and packaging components for regulatory compliance.
Maintain regulatory databases and submission trackers.
Support product lifecycle management activities, including change controls and post-approval submissions.
Respond to health authority queries within prescribed timelines.
Coordinate with Regulatory Consultants, European partners, and customers for submission-related activities.
Participate in regulatory inspections and audits whenever required.

Preferred candidate profile

To manage Regulatory Affairs activities for Solid Oral Dosage (OSD) products across the UK MHRA and European markets. The role involves preparing, reviewing, compiling, and submitting regulatory dossiers while ensuring compliance with applicable regulatory guidelines and supporting timely product approvals and lifecycle management.

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