Senior Manager-Regulatory Affairs

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 Senior Manager Regulatory Affairs, Consumer CMC for Global market. In this role candidate should have experience in regulatory affairs (team handling experience) while essential exposure lifecycle document management (LCM). Need to have good knowledge of ICH guidelines and post-approval submissions and regulations.ResponsibilitiesThe Role demands expertise with demonstrating ability to execute responsibility in a highly regulated & process driven environment, the Person will be responsible for all the activities related to following things: 1.Responsible for overseeing the project progress, managing the team, ensuring the project stays on schedule and maintaining communication with stakeholders.2.Responsible for implementing CMC regulatory strategies for assigned consumer products in accordance with global regulations, guidance and defined regulatory strategies. 3.Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data, quality control of the CMC documents ensuring the project meets the goals and standards.4.Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.5.Preparation of Quality Overall Summaries (QOS) for drug product and drug substance.6.Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets.7.Submission of relevant sections in Annual Reports for US Market.8.Preparing RA expert response for deficiency letters from various regulatory authorities.9.Assessment of registration documentation for consumer products as per the current Health Authority requirements.10.Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.11.Post-approval submission knowledge for EU markets. Qualifications we seek in youMinimum Qualifications / Skills•Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry. •Mandatory Knowledge of ICH and FDA guideline for global market market. •Advanced tableau/power bi knowledge needed.•Analyzing and mining business data to identify correlations and discover patterns from various data points.•Should be advance level in English language. Preferred Qualifications/ Skills•Facilitate effective communication and collaboration among team members. Provide guidance, support and mentorship to team members.•Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission.•Ability to identify problems and work with team to formulate a potential course of action.•Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously.•Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables.•Must demonstrate oral and written communication skills and the ability to communicate issues in a succinct and logical manner. •Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations and takes a new perspective using existing solutions.•Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.•Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures.•Depending on experience level, mentor newly hired staff or lead a team of junior staff.•Flexibility in responding to changing priorities or dealing with unexpected events. •Capability to handle multiple priorities and balance work to achieve business goals.