Job title: DG – Lead Associate – Regulatory Affairs
Job description: With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. Now, we&rsquore calling all you rule-breakers and risk-takers who see the world diffe
With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world&rsquos biggest brands&mdashand we have fun doing it. Now, we&rsquore calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come, transform with us. Are you the one we are looking for We are inviting applications for the role of Lead Associate, Regulatory affairs! In this role, you will be responsible to work on deadlines, in a fairly high pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy. Responsibilities The Role demands for a highly qualified professional who should have CMC experience under regulatory affairs domain. Lead Associate will be responsible for all the activities related to – .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. .Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance. .Assess and communicate potential regulatory risks and propose mitigation strategies. .Deliver all regulatory results for assigned products across the product lifecycle .Identify and communicate potential regulatory issues to GRACS CMC, as needed .Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance). .Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners. .Proven flexibility in responding to changing priorities or taking care of unexpected events. .Capability to handle multiple priorities and balance work to achieve business goals. Minimum Qualifications .Bachelor&rsquos degree in pharma / Science .Strong financial analytical skills and problem solving skills. .Effective communicate in writing and verbally to senior management. .Experience in balancing customer facing role and work assessments. .Self-starter and have analytical, prioritization skills .Ability to balance customer governance meetings Preferred qualifications .Able to further working relationships with the team, peers and clients, scheduling flexibility required .Overall candidate should have decision-making, research and analytics approach and in numbers. .Good people and customer handling skills. .Effective communication and interpersonal skill. 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 . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Location: Mumbai, Maharashtra
Job date: Mon, 18 Jul 2022 22:18:19 GMT
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