Job Description
Ready to shape the future of work
At Genpact, we don't just adapt to change-we drive it. AI and digital innovation are redefining industries, and we're leading the charge. Genpact's AI Gigafactory, our industry-first accelerator, is an example of how we're scaling advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. From large-scale models to agentic AI, our breakthrough solutions tackle companies' most complex challenges.
If you thrive in a fast-moving, tech-driven environment, love solving real-world problems, and want to be part of a team that's shaping the future, this is your moment.
Genpact (NYSE: G) is an advanced technology services and solutions company that delivers lasting value for leading enterprises globally. Through our deep business knowledge, operational excellence, and cutting-edge solutions - we help companies across industries get ahead and stay ahead. Powered by curiosity, courage, and innovation, our teams implement data, technology, and AI to create tomorrow, today. Get to know us at genpact.com and on LinkedIn, X, YouTube, and Facebook.
Inviting applications for the role of Lead consultant Regulatory Affairs Expert in CMC and labelling for Southern and Middle Africa markets.
In this role Candidate should have experience in regulatory affairs while essential exposure to local regulatory affairs lifecycle management ('LCM'), primary contact for local heath authority (HA), HA invoices check and product maintenance activities for assigned products and also need to have good knowledge of ICH guidelines and regulatory guidelines for Middle and Southern Africa markets. In depth working knowledge of CMC variations, renewal, labelling, and PSUR submissions. Expertise in designing regulatory strategy and decision with respect to CMC filing, renewal, PSUR and labeling submissions.
Responsibilities
.Authoring (including variation application form and draft cover letter) and reviewing of documents for Variations (administrative, labeling, CMC, safety, dossier harmonization), renewal, and PSUR.
.Handling of deficiency letters (DLs) according to the mentioned timelines in the regulations
.Providing variation submission strategy & category and RA Assessment through change management system
.Coordinate artwork changes for submission and implementation (triggered due to LCM activities and safety updates)
.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 Southern and Middle Africa markets.
.Responsible for maintaining internal tracker for CMC, renewal, labelling and PSUR submissions.
Qualifications we seek in you!
Minimum Qualifications / Skills
.B. 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 respect and integrity, customer focus, and innovation. 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.