Manager/Sr. Manager-Regulatory Affairs Location: Gurgaon, Haryana, India Category: Research & Development Job Type: Full Time Regular Job Id: R-72432 Purpose: Regulatory planning to meet the affiliate and responsible countries' business needs, management & compliance of regulatory tools as per functional processes. Responsible and accountable for regulatory activities and performance in registering new products (including product line extensions) and new indications. Prepare submissions and gain approval for new products and indications. Maintain regulatory compliance for marketed products, including product maintenance such as manufacturing or labelling (Product Information and packaging) variations, renewals, pharmacovigilance activities, etc. Build partnerships with officials in the Regulatory Authority and stay updated on changes in the regulatory environment. Customers include all medical/marketing/business personnel within the affiliate, the Drug Regulatory Agency, and Area regulatory management. Primary Responsibilities: Regulatory Planning Regulatory Plan Development Plan, review, and recommend the best regulatory strategy for submissions, including regulatory timelines, during the planning phase for pipeline products of the assigned portfolio based on regulatory expertise with country regulations & MOH processes. Manage and ensure the Regulatory Plan for assigned countries is in alignment with Product Teams & Area strategies, and the country’s business plan. Process Management Coordinate the process with cross-functional members of the affiliate, sites, and corporate (Legal, Administration, etc.) to ensure timely availability of required documents and other requirements for dossier preparation. Actively participate in cross-functional teams within the affiliate and provide regulatory expertise to ensure regulatory timelines are met or improved. Regulatory Tools Timely update of data in regulatory tools as per global process. Ensure that data is complete, accurate, and communicated appropriately to relevant stakeholders. Submissions and Approvals Dossier Preparation Prepare a quality regulatory dossier and submit within the planned affiliate timelines. Request and obtain the necessary regulatory items. Prepare/format the dossier to meet regulatory requirements. Implement the submission and archive appropriately. Gain Regulatory Approval Gain Drug Regulatory Agency (DRA) approvals to meet the affiliate product launch plans and ensure product maintenance. Activities include: Provide quality responses to the Ministry of Health (MOH) by the due date. Complete regulatory approval process and gain product licenses. Communicate product approval. Archive submission dossier and approval documents. Track post-approval commitments. Perform regulatory responsibilities related to packaging development. Ensure the local label creation and packaging development meet local and corporate criteria and support business needs. Metrics Review Prepare periodic regulatory reports on submissions and approvals, and communicate to local management. Provide regulatory metrics aligned with Area & IC Regulatory Affairs criteria to measure regulatory performance. Regulatory Compliance Compliance Maintenance Take appropriate actions to maintain all marketed products in compliance with regulatory and corporate requirements. Conduct periodic compliance self-audits. Perform activities related to pharmacovigilance according to corporate and local regulations. Take corrective actions based on regulatory audit findings. Good Regulatory Practices (GRP) Develop, update, and implement SOPs required by Global Regulatory Affairs policies, local regulations, and Good Regulatory Practices. Complete Global and/or IC Regulatory Core Curriculum and GRP training. Regulatory Influence External Regulatory Customer Relations Establish relationships with key regulatory officials to foster a positive regulatory environment for business and research. Regulatory Environment Changes Stay updated on local regulations and DRA organizational structures and communicate changes to affected parties. Influence Strategy Support in developing and implementing external regulations and influence strategies. Internal Affiliate Organisation Learn and understand the local affiliate organization and functions. Build partnerships and credibility to maximize regulatory value in business decisions. Regulatory Value Proactively use regulatory tools to communicate with affiliate business partners on the global regulatory status of new products and local regulatory trends. Educate the affiliate on the value the regulatory function contributes to the business. Additional Responsibilities (if applicable) Provide technical support with Health Economic data for Drug Regulatory Agency price negotiations. Provide regulatory support for locally manufactured products and clinical trials. Perform responsibilities of ALRP/Alternate ALRP/Delegate ALRP as assigned, ensuring compliance with regulatory and corporate requirements. Minimum Qualification Requirements: B.Pharm, M.Pharm, BSc or Master’s Degree in Chemistry or Biotechnology, or related areas, or MD (licensed in the country, if applicable). Minimum 3 years of regulatory affairs or related experience. In-depth knowledge of local regulations for pharmaceutical product registration and Regulatory Corporate policies. Understanding of the local business decision-making process impacting the regulatory strategy. Other Information/Additional Preferences: Good knowledge of written and spoken English; additional languages beneficial. Broad understanding of regulatory requirements and Lilly’s goals. Competent project management skills. Strong oral/written communication & interpersonal skills. Ability to handle conflict, show initiative, and possess negotiation skills. Analytical skills, accuracy, reliability, creative thinking, and problem-solving ability. Customer focus.
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