Hiring for Management Trainee/assistant Manager Biologics Mumbai for Exp. 3 - 8 Years at GENPACT IND (Job in Mumbai)
(Not Shown) (Please mention IndiaDynamics.com when contacting)
Job Description:Job Location: Mumbai Department: Regulatory Affairs Experience: 3 and above years in Pharma Regulatory Affairs Education: B.Sc./M.Sc. in Biotechnology or Microbiology or Science/Pharma degree Life cycle management of the various biological molecules (biosimilars) Compilation of the dossier for the various molecules and submission of the dossier in the various countries/markets as per their regulatory requirements Awareness of molecular biology techniques Responsible for following cGMP/GLP and ICH guidelines and Process Validation Experience in authoring (and global creating strategies for) post-approval CMC submissions (variations, supplements) Experience in within a Regulatory Affairs department supporting small-molecule and/ or biological drugs Preparing US Annual Reports and international license renewals Good knowledge of ICH guidelines and CTD structure Dossiers preparation & submission in CTD modules Knowledge of manufacturing documents like batch records, specifications, analytical methods, validation reports, stability data Collecting, collating and evaluating scientific data that has been researched by colleagues Developing and writing clear arguments and explanations for new product licenses and license renewals Demonstrate leadership in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc. Dependent on experience level, mentor newly hired staff. Responsible for the preparation and review of information required for development of regulatory CMC Designing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements and critically evaluating supporting documentation to assess acceptability and identify potential risks. Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. Assess and communicate potential regulatory risks and propose mitigation strategies. Deliver all regulatory milestones for assigned products across the product lifecycle Serve as the CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle. Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks. Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal. Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity. Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity. Manage execution of CMC documentation including NDA/BLA/MAA, and responses to health authority questions per established business processes and systems.