Head of Regulatory, Quality and Government Affairs South-Asia

1 day ago

Gurgaon, Haryana, India Fresenius Medical Care Full time ₹ 12,00,000 - ₹ 36,00,000 per year
  • Responsible for Medical Device and Drug registration in CDSCO, State FDA office and other government office. Lead negotiations with key health authority agencies during development, registration, and product lifecycle activities to resolve regulatory issues and/or negotiate approvals; establish and maintain proactive and professional communication & relationship with agencies.
  • Execution of Regulatory Submission plan in each of countries in hub.
  • Representing FME India in highly visible and potentially intense forums such as FICCI/CII/APACMED for new regulations impacting the business in interactions with Government and Forum meetings.
  • Identify key officials, develop, and execute plan to engage with those key officials of MOH (Department of Drug Controller General of India), Ministry of Chemicals & Fertilizer (Dept. of Pharmaceuticals) etc.
  • To have overall responsibility for the management of the regulatory functions and ensure that new products and specifications are registered in a timely fashion.
  • Provide regulatory expertise to global product development and regulatory teams.
  • To have overall responsibility for ensuring that all state and central regulatory requirements are addressed.
  • Build strong teams and structures with dedicated focus in country and Hub region, including hub budget responsibility and control according to finance policies and guidelines, build, lead and continuously develop the team.
  • Responsible for all regulatory affairs and quality tasks in the hub incl. management of product complaints and product regulatory conformity, safety, and post market systems in all countries of Hub as well as communication to applicable SysQaRa functions in accordance with corporate SOPs.
  • Provide leadership and oversight for the strategic and technical regulatory direction for the registration for all FME MedTech and pharmaceutical products relevant in the Hub (incl. medical devices, medicinal products, combination products, software as MD, etc.).
  • Develop and agree on regulatory strategies for national and Hub regulatory topics based on business requirements and broader regionally aligned regulatory affairs (RA) strategy.
  • Monitor, evaluate and inform key internal stakeholders about applicable national and hub regulatory requirements; coordinate internal implementation and actively contribute to the development of new regulatory requirements.
  • Implement a Regulatory intelligence system for the Hub as part of the regional RI system
  • Responsible for the fulfillment and compliance with all the hub regulatory requirements
  • Monitor regulatory compliance of distributors and critical suppliers
  • Ensure timely, clear communications on regulatory status / issues / risks with key internal stakeholders esp. in Commercial Operations and Verticals, create transparency and thereby contribute to portfolio decisions through guidance on regulatory strategy and efforts.
  • Fulfill all duties associated to the corporate MAH for medical products and local MAH and associated product responsibilities, local and hub key contact for authorities. including performing pharmacovigilance reporting as well as reporting and execution of safety actions in accordance with corporate SOPs and local regulations
  • Report customer complaints, incidents and any potential safety issues in compliance with corporate SOPs and execute medical device incident/adverse event reporting in compliance with local country regulations.
  • Support and ensure execution of field safety actions in affected markets and execute field action reporting to health authorities in accordance with applicable regulations.
  • Implement and maintain effective Product Quality Management, Safety systems for all applicable processes and functions of the legal entities within the sub-region (hub).
  • Provide leadership to country LMRs to ensure the implementation, maintenance and continual improvement of the Global Management System (GMS) and the applicable specific management systems according to corporate requirements and in compliance with local regulatory and statutory requirements.
  • Ensure audit and inspection readiness including preparation, realization and follow-up of external and internal audits and inspections. In case of detected deviations and non-conformities, ensure the effective, efficient and timely implementation of required corrections, corrective and/or preventive actions.
  • Ensure safe, compliant and efficient release and distribution of products imported and marketed by FME within the distribution quality function. Ensure the fulfillment of GDP requirements for distribution of medical devices and drugs in all countries in hub
  • Lead the compliance with regulatory requirements and effective quality management to ensure available, safe, and effective products, ensuring that the processes of import, storage, re labeling, traceability and distribution of imported products meet the regulatory conformity.
  • Manage and provide regulatory and quality support in the import/export of products and tender processes

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