Regulatory Affairs Lead Associate Job at Genpact, Apply Now!
Looking to advance your career in Regulatory Affairs? Genpact, a global leader in digital operations and professional services, is hiring a Lead Associate – Regulatory Affairs for its Hyderabad office. If you have expertise in lifecycle document management (LCM) and a strong understanding of ICH and FDA guidelines, this is your chance to work with one of the top players in the industry. Apply now for this full-time operations role and contribute to global regulatory strategies for consumer products.
Job Title: Lead Associate, Regulatory Affairs
Location: India-Hyderabad
Job ID: LIF020503
About The Company
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.
Job Description:
Inviting applications for the role of Lead Associate, Regulatory Affairs for Consumer
CMC for Global Markets. The candidate should have experience in regulatory affairs with essential exposure to lifecycle document management (LCM) and good knowledge of ICH and FDA guidelines for the Global market.- Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations.
- Writing CMC quality documents for the dossier and/or the entire module 3 from raw data.
- Reviewing and evaluating existing quality documentation and updating as required during Project Renewals.
- Preparation of Quality Overall Summaries (QOS).
- Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.
- Submission of relevant sections in Annual Reports for the US Market.
- Preparing RA expert response for deficiency letters from regulatory authorities.
- Assessment of registration documentation for consumer products.
- Knowledge of manufacturing, analytical, validation, and stability documents.
- Post-approval submission knowledge for EU markets.
Regulatory Affairs Lead Associate Job Qualifications
Minimum Qualifications:
B.Sc / M.Sc / B. Pharmacy / M. Pharmacy
Preferred Qualifications/ Skills:
- Expertise in VeevaVault will be a plus point.
- Ability to prioritize tasks, work with a team, identify problems, and communicate effectively.
- Decision-making, research, analytics skills.
- Capability to handle multiple priorities, effective leadership, communication, and interpersonal skills.
- Good people and customer handling skills, time management, and organizational skills.
Keywords: Lead Associate, Regulatory Affairs, Genpact, Full Time, Operations, Job Posting
