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 of required documentation.
Site Coordination
- Visit manufacturing sites and CMOs, when required, to facilitate document collection and resolve documentation-related issues.
- Coordinate meetings and discussions with site personnel to ensure timely closure of pending document requests.
- Build effective working relationships with site teams to improve responsiveness and document availability.
Documentation Management
- Maintain organized electronic and physical records of received documents and dossiers.
- Ensure documents are properly filed and readily accessible to the Regulatory Affairs team.
- Support retrieval of documents whenever required.
Key Skills & Competencies
- Strong coordination and follow-up skills.
- Excellent communication and interpersonal skills.
- Strong organizational and documentation management abilities.
- Ability to manage multiple activities and deadlines simultaneously.
- Good stakeholder management skills.
- Proficiency in MS Excel, Word, PowerPoint, Outlook, and Teams.
- Willingness to travel to manufacturing sites and CMOs as required.
Educational Qualification.
- Bachelor's Degree in Pharmacy, Life Sciences, Management, or related fields will be an added advantage.
Experience
- 2–5 years of experience in project coordination, operations, documentation management, vendor coordination, manufacturing coordination, supply chain coordination, or related functions.
- Experience working with manufacturing sites, vendors, CMOs, or cross-functional teams will be preferred.
- Pharmaceutical industry experience is desirable but not mandatory.
Pay: ₹400,000.00 - ₹600,000.00 per year
Benefits:
- Health insurance
- Provident Fund
Work Location: In person
