Job Description

With a start-up 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 diff

With a start-up 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 ofLead Associate, Regulatory Affairs You will be responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies. You will also be responsible for the preparation and review of information required for development of regulatory CMC submission (i.e., US-Annual Reports). Responsibilities: Responsible to provide regulatory filing support for assigned Annual Report by providing required submission activities (compilation of required data (CMC/ancillary documents), coordination, reviewing, and release) in accordance to regulatory requirements and timelines. Respond to health authority questions or local subsidiary requests for additional information to support the Annual Reports. Administrative Content (Module 1) preparation for Annual Reports-US market. To handle Regulatory document management systems: GCM-Trackwise, ORION -COGNOS, VEEVA, REDS, IPI etc. Coordination with clients in tracking and status update of project plans. Ensure a timely submission of Annual Reports as per the CMC content release date. Willing to work for US Shift. Other skills we seek in you! Demonstrated understanding of regulatory affairs and pharmaceutical registrations Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners. Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. Capability to prioritize multiple priorities and balance work to achieve business goals. Demonstrated effective leadership, communication, and interpersonal skills. Qualifications we seek in you! Bachelor&rsquos or master&rsquos degree (or other advanced degree) preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline requirement. Bachelor&rsquos degree preferably in Pharmacy, Biological Science, Chemistry, Nursing, or related discipline required related experience in the including research manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products or related fields. Alternatively, a master&rsquos or other advanced degree with relevant experience in pharmaceutical industry. Excellent organizational skills and a proven ability to multi task. 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 proficiency in REDS or advanced document control system. Superior attentiveness to details. Ability to generate innovative solutions to problems and effectively work with and communicate to key stakeholders. Flexibility in responding to changing priorities or dealing with unexpected events. Capability to handle multiple priorities and balance work to achieve business goals. Effective leadership, communication and interpersonal skills. Ability to prioritize tasks to meet deadlines and collaborate with a team when help is needed. Ability to identify problems and work with team to formulate a potential course of action. 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 www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.