Manager - Regulatory Affairs

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Genpact (NYSE : G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions – we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.

Inviting applications for the role of Manager or Senior Manager, Regulatory affairs-

Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with 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.

Responsibilities :

• Leading project teams, providing technical guidance, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
• The core responsibility will be to review the authored documents, compare them with source documents, ensure there are no transcription or formatting errors, no quality errors, and ensure compliance with regulatory guidelines.
• Maintaining the quality of documents through quality reviews ensuring “No Queries” received from Health Authorities
• Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the 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.
• Ability to lead client meetings and managing project governance.
• Deliver on agreed SLAs with clients at contract and account / project level. Meet all monthly reporting / business metrics / KPIs requirements and manage internal control processes.
• Planning the project by understanding the client needs, channelizing appropriate resources, managing project deliverables, training team as well as client on a need-basis and providing solutions in real time.
• Improvise the process and outcomes by implementing continuous improvement initiatives leveraging six-sigma methodologies, RPA / AI opportunities for harmonization, simplification, and automation
• Assess and communicate potential regulatory risks and propose mitigation strategies.
• Ability to prioritize & execute the project according to the project plan / timelines / schedules.
• Ensure established policies and procedures of the organization / client are followed and ensure compliance.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate project status & report to stakeholders using different communication channels.
• Contribute to draft Request for information and / or Request for proposals for new client / business opportunities. Provide inputs 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.
• Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.
• Superior attentiveness to detail & has a strong regulatory background.
• Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
• Demonstrated ability to generate innovative solutions to problems and effectively collaborate with and communicate to key stakeholders.
• Demonstrated flexibility in responding to changing priorities, multi-tasking and dealing with unexpected events.
• Demonstrated effective leadership, communication, and interpersonal skills.

Qualifications we seek in you!

Bachelor’s or master’s degree required in science, engineering or related field (advanced degree preferred).

Why join Genpact?

Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters : Up.

Let’s build tomorrow together.