The Project Coordinator – Regulatory Affairs will be responsible for coordinating with manufacturing sites, Contract Manufacturing Organizations (CMOs), and internal stakeholders to obtain, track, and organize documents and dossiers required by the Regulatory Affairs team. The role will primarily focus on document collection, follow-up, tracking, and coordination activities to ensure timely availability of complete documentation for regulatory projects. The position will serve as a key link between the Regulatory Affairs team and manufacturing sites/CMOs, enabling the Regulatory Affairs team to focus on dossier preparation, submissions, regulatory strategy, and authority communications.

Key Responsibilities

Document & Dossier Coordination
- Coordinate with manufacturing sites and CMOs for collection of regulatory documents and dossiers.
- Follow up with site teams to obtain requested documents within agreed timelines.
- Ensure complete sets of documents are received as per Regulatory Affairs requirements.
- Coordinate collection of updated and revised documents whenever required.




- Organize and maintain dossiers and supporting documents received from manufacturing sites and CMOs.

Stakeholder Coordination
- Act as the primary point of contact between the Regulatory Affairs team and manufacturing sites/CMOs for documentation-related activities.
- Coordinate with departments such as QA, QC, Production, R&D;, Validation, Engineering, Warehouse, and Supply Chain to obtain required documents.
- Facilitate communication and follow-up on pending actions.
- Escalate delays in document availability to the Regulatory Affairs Manager when required.

Tracking & Reporting
- Maintain trackers for document requests, pending items, and dossier status.
- Monitor document readiness against project timelines.
- Provide periodic updates to the Regulatory Affairs team regarding pending and completed activities.
- Support planning of regulatory projects by ensuring timely availability o

📌 Project Coordinator- Regulatory Affairs (Navi Mumbai)
🏢 SRS Pharmaceuticals Private
📍 Navi Mumbai