We are inviting applications for the role of Lead Associate or Lead Consultant, Regulatory affairs-CMC.
• Leading project teams, ensuring maintenance of team records and process-related documentation i.e process maps, job aids, project trackers, checklists, etc.
• 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.
• It includes regulatory assessment; preparation and quality review of pre & post approval regulatory submission dossiers; and compliance activities
• Extensive experience in end-to-end life-cycle management of pharmaceuticals for EU, US and ROW markets for a vast range of therapeutic areas.
• 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.
• 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 and providing solutions in real time.
• 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 on project status & reporting 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 evaluate 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.
• 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, Pharmacy or related field (advanced degree preferred) with minimum 5 years of CMC RA experience
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit http://www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.