Senior Associate – Regulatory Affairs (CMC)

<p><strong>Responsibilities:</strong></p> <ul> <li>Manage the preparation and submission of new product registrations, post approval submission, and follow-up closely on queries and through approval</li> <li>Responsible for reviewing and writing CMC modules 2 and 3</li> <li>Exposure to EU and CIS region in regulatory filings</li> <li>Herbal product development background</li> <li>Manage and coordinate product life cycle management</li> <li>Ensure regulatory compliance with local regulatory requirements</li> <li>Foster and maintain professional relationships with the health authorities</li> <li>Provide regulatory support including timely registration of new product and line extensions to support new product launches and tender applications when necessary</li> <li>Maintain regulatory work processes and tracking tools that improve performance levels and transparency</li> <li>Exposure in writing of Product Quality Review</li> <li>Promote regulatory intelligence in both local and regional initiatives</li> <li>Develop regulatory strategies, prepare regulatory applications, and support maintenance activities within relevant therapy areas</li> <li>Execution of regulatory strategies (local and regional) that are in line with the business plan</li> <li>Complete regulatory activities for a defined number of products to ensure all regulatory obligations and business objectives are met</li> <li>Ensure adherence to timelines and quality set parameters</li> <li>Review of formulation, generation of ingredient list, and claims per set standards</li> <li>Compilation and review of labeling components per SOP</li> </ul> <p><strong>&nbsp;</strong></p> <p><strong>Deliverables:</strong></p> <ul> <li>CMC modules 2 and 3</li> <li>Management of the preparation and submission of new product registrations, post approval submissions, and follow-up on queries through approval</li> <li>Review of CMC modules</li> <li>Execution of regulatory strategies (local and regional) that are in line with the business plan</li> <li>Compilation of PQR as per SOP – Summary report of variations submitted as per the specified period.</li> <li>Review of formulation, generation of ingredient list, and claims per set standards</li> <li>Compilation and review of labeling components per SOP</li> </ul> <p>&nbsp;</p> <p><strong>Experience/Qualifications:</strong></p> <ul> <li>Bachelor’s/Master’s degree in Life Science/Pharma</li> <li>Four to six years of relevant work experience</li> <li>RAPS certification is desirable</li> </ul>