Dr. Reddy's Laboratories
Location
Hyderabad | India
Job description
Role Description:
Preparing the NDA submission for Emerging Markets, communicating with regulatory agencies, and managing the regulatory review process. Ensuring that the drug is approved for marketing in a timely manner and that it meets the regulatory requirements for commercialization. Timely update and preparation of dossier and documents as well as responses to the queries raised by regulatory agencies. Registration application preparation including administrative documents and GMP audit support for global markets. Preparation of gap analysis for the registration in regulated and semi regulated markets. Review, assessment and establishing & tracking effective change control management coming for regulatory review and approval. Work with a team of regulatory affairs experts of various countries to ensure that the NDA is submitted correctly and meets respective regulatory agencies requirements. Lead regulatory due diligence activities for innovative pipeline assets, identify necessary clinical and regulatory requirements needed for regulatory approval in Emerging Markets. Identify and assess regulatory risks, mitigations, opportunities, and contingencies. Liaise closely with the CMC and clinical teams to ensure all regulatory requirements are met and all information needed for ongoing documentation and registration is produced. Review Clinical trial protocols, Clinical study report contents and approval requirements to facilitate CT NOCs and marketing authorization approval by regulatory agencies Prepare meeting requests, briefing documents, coordinate and prepare teams for regulatory authority interactions. Establish and manage relationships with external regulatory authorities, prepare meeting requests, briefing documents, lead regulatory authority interactions and maintain correspondence / records of such interactions Ensure effective planning, preparation and timely submission of INDs, NDAs, BLAs and other regulatory documents and applications, as required Provide strategic direction (and content input) on product labelling Ensure adherence to and continuous improvement of standards, processes and guidelines for regulatory submissions of innovative products End to End RA function support for allocated asset/country: Guide by providing regulatory strategy for complex molecules/asset. Provide functional support to RA and CFT members to meet the current regulatory requirements and guidelines in order to secure the acceptances, approvals and launches of innovative assets. Accountable for decisions and appropriateness of submission documentation to support successful ANDAs/ANDSs/Dossiers and other submissions to various agencies. Deficiency Management: Coordinates and Collaborates with multi-disciplinary matrixed teams in relation to pending deficiencies to meet timelines with appropriate prioritization. Guides RA and CFT members by providing appropriate regulatory strategies to ensure the accuracy and adequacy of the response. Support the Launch team - Supports the launch team by providing necessary regulatory strategies, inputs and decisions for the proposed changes, if any, within the regulatory framework thus safeguarding the regulatory compliance and the launch of the product. Ensures the smooth transition of the approved and launched products to the Life-cycle Management (LCM) Process along with the history of approval process Qualification & Experience: PhD, Master’s in science / pharmacy, advanced degree preferred. Expert understanding of drug development process and understanding of scientific content and complexities related to NBEs Direct experience in developing strategy and leading teams through interactions with regulatory agencies in Emerging markets Around 10 years of overall experience in Industry with minimum 5 years’ experience in regulatory domain with knowledge new drug applications. Hands-on experience of clinico-regulatory requirements (DD, market study, CT strategy etc.) to enable filing NCE /NBE products across EM.Job tags
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