Lead Consultant, Regulatory Affairs!

Lead Consultant, Regulatory Affairs!- LIF019287 Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000+ people across 30+ countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose – the relentless pursuit of a world that works better for people – we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI. Inviting applications for the role of Lead Associate/Lead Consultant , Regulatory Affairs! In this role, you are expected to work on post-approval submissions for pharmaceuticals for multiple dosage forms across various regions. You will be expected to update CMC sections, author Justification and Rationale, prepare submissions in regulatory data management tools, update systems, evaluate change controls, prepare regulatory strategy, ensure regulatory compliance, prepare submission plans, respond to health authority queries, and peer review submissions of other colleagues.  Responsibilities:

• Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance wi th global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products. 

• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under direction of team scientists.

• Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data. 

• Able to prioritize & execute the project according to the project plan/timelines/schedules. 

• Work with cross-functional team s to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.

• Understand ing of job responsibilities & processes of cross-functional teams , manufacturing sites, Quality Assurance, Quality control, etc . Prior experience in these departments is preferable .

• Experience in RA/ QA/ QC system and tools like SAP, documentum , Veeva, LIMS, spotfire , Power BI, etc is preferrable.

• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.

• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

• Ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.

• Active participation in departmental improvement activities such as system modifications, maintenance of standard operating procedures, internal guidelines, etc. 

• Demonstrated f lexibility in responding to changing priorities , multi-tasking and dealing with unexpected events.

• Effective leadership, communication, and interpersonal skills.

• Advanced knowledge of MS Office.

• Superior attentiveness to detail.