Specialist - Regulatory Affairs - Operations
Ready to turn bold ideas into real-world impact?
At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or agentic AI, our breakthrough solutions tackle companies’ most complex challenges.
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Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
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Job Description
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 (D Ls) 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
Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs
Certifications
Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)
Required Skills
Client Relations, Collaboration Tools, Data Analytics, Generative AI, Lean Six Sigma (LSS), People Leadership, Personal Effectiveness, Storytelling
Language
English
Language Proficiency -
Intermediate - B1
Additional Job Location -
Job Type
Regular
Master Skill List -
Regulatory Affairs - Operations
Remote Type -
Hybrid
Work Shift -
Flex Time (India)
Why join Genpact?
- Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
- Make an impact – Help global enterprises solve business challenges that matter
- Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
- Work with the best – Join 140,000+ bold thinkers and problem-solvers who push boundaries every day
- Thrive in a values-driven culture – Our courage, curiosity, and incisiveness - built on a foundation of integrity and inclusion - allow your ideas to fuel progress
Come join the 140,000+ coders, tech shapers, and growth makers at Genpact and take your career in the only direction that matters: Up.
Let’s build tomorrow together.
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 'starter kit,' paying to apply, or purchasing equipment or training.
