Job Description

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 Lead Consultant Regulatory Affairs, CMC and labelling for Dubai market In this role Candidate should have experience in regulatory affairs while essential exposure to local regulatory affairs lifecycle management (&ldquoLCM") and product maintenance activities for assigned products and also need to have good knowledge of ICH guideline and regulatory guideline for local markets. In depth working knowledge of DMF, renewal, labelling and CMC variations. Post approval submissions and expertise in designing regulatory strategy and decision with respect to CMC filing. Responsibilities . Authoring and reviewing documents for post approval changes, renewal, labelling and DMF. . Handling of Post approval changes, assigning of proper category to particular change based on Regulatory guidelines. . Escalate, notify, and resolve any issues that may impact final CMC and labeling submission. . End to end responsibility/ Life cycle management of product registered in Dubai market. . Responsible for maintaining internal tracker for DMF, renewal, labelling and CMC submissions as per anniversary. Qualifications we seek in you! Minimum Qualifications / Skills . B. Pharmacy . M. Pharmacy Preferred Qualifications/ Skills . Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission. . 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. . 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. 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. Get to know us at and on , , , and . Furthermore, please do note that Genpact does not charge fees to process job applications and applicants are not required to pay to participate in our hiring process in any other way. Examples of such scams include purchasing a %27starter kit,%27 paying to apply, or purchasing equipment or training.

foundit