Head of Regulatory Affairs

* Spearhead regulatory activities for pharmaceutical and medical device products, ensuring compliance with DGDA and international guidelines. * Architect and submit regulatory dossiers, handling product registration, renewal, and variation submissions to regulatory authorities. * Drive compliance with local and international regulatory requirements, including DGDA, US FDA, EU, MDR, and WHO guidelines. * Collaborate with cross-functional teams, including QA, production, and R&D, to coordinate regulatory documentation and ensure seamless processes. * Manage and maintain regulatory documentation and databases, ensuring accuracy and timeliness. * Oversee product labeling, packaging, and promotional content, verifying compliance with regulatory standards. * Champion audit and inspection readiness, supporting regulatory affairs and ensuring a state of continuous compliance. * Monitor regulatory changes, implementing updates and ensuring timely adaptation to new requirements. * Lead regulatory activities for drugs, narcotics, BSTI, and DPDT, handling submissions and approvals. * Negotiate product pricing with regulatory authorities, securing approvals and re-fixations as needed. * Facilitate import product registration and renewal, ensuring uninterrupted market access. * Communicate effectively with toll manufacturing companies, regulatory authorities, and internal stakeholders. * Develop and implement CE marking documentation for medical devices, as required. * Analyze and respond to regulatory queries, providing timely and effective solutions.