Lead Consultant - Regulatory Affairs
Lead Consultant - Regulatory Affairs
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Job Description
Ready to build the future with AI
At Genpact we dont just keep up with technologywe set the pace. AI and digital innovation are redefining industries and were leading the charge. Genpacts AI Gigafactory our industry-first accelerator is an example of how were 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 innovation-driven environment love building and deploying cutting-edge AI solutions and want to push the boundaries of whats possible 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 and on LinkedIn X YouTube and Facebook.
Inviting applications for the role of Management Trainee/ Assistant Manager- Lead Associate or Lead Consultant Regulatory affairs.
Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.
Responsibilities:
The core responsibility will be to review the authored documents compare them with source documents ensure there are no transcription or formatting errors no quality errors and ensure compliance with regulatory guidelines.
Maintaining the quality of documents through quality reviews ensuring No Queries received from Health Authorities
Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under the direction of team scientists.
Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Able to prioritize & execute the project according to the project plan/timelines/schedules.
Work with cross-functional teams to track and follow up outstanding documentation coordinate on project status & reporting to stakeholders using different communication channels.
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).
Ability to generate innovative solutions to problems and effectively collaborate with and communicate with key stakeholders.
Active participation in departmental improvement activities such as system modifications maintenance of standard operating procedures internal guidelines etc.
Demonstrated flexibility in responding to changing priorities multi-tasking and dealing with unexpected events.
Effective leadership communication and interpersonal skills.
Advanced knowledge of MS Office.
Superior attentiveness to detail & has a strong regulatory background.
Qualifications we seek in you!
Bachelors or masters degree required in science engineering or related field (advanced degree preferred).
Why join Genpact
Lead AI-first transformation Build and scale AI solutions that redefine industries
Make an impact Drive change for global enterprises and solve business challenges that matter
Accelerate your careerGain hands-on experience world-class training mentorship and AI certifications to advance your skills
Grow with the best Learn from top engineers data scientists and AI experts in a dynamic fast-moving workplace
Committed to ethical AI Work in an environment where governance transparency and security are at the core of everything we build
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 140000 coders tech shapers and growth makers at Genpact and take your career in the only direction that matters: Up.
Lets 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.
Required Experience:
Contract
Employment Type
Full-Time
