Lead Associate – Regulatory Affairs

Ready to shape the future of work
At Genpact we dont just adapt to changewe drive it. 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.
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We are inviting applications for the role of Lead Associate or Lead Consultant Regulatory Affairs.
Responsibilities:
Responsible for leading and executing CMC regulatory strategies for assigned postapproval pharmaceutical products in alignment with global regulations guidance and defined regulatory strategies including preparation and critical review of data and documents required for postapproval CMC submissions and lifecycle management.
Accountable for authoring reviewing and coordinating CMC documentation to support worldwide postapproval changes and lifecycle activities (variations supplements amendments) for commercial products under the strategic direction of senior regulatory CMC scientists or product leads.
Experienced in evaluating scientific and technical information to assess the merits and regulatory impact of proposed postapproval changes ensuring that rationales are clearly articulated riskbased and fully supported by appropriate data.
Able to prioritize plan and drive multiple CMC postapproval projects in parallel ensuring timely preparation review and submission of highquality dossiers in line with agreed project plans regulatory timelines and internal milestones.
Works effectively with crossfunctional teams (e.g. QA QC manufacturing supply chain packaging device and analytics) to track and close out documentation gaps coordinate on change implementation status and provide clear concise regulatory updates to stakeholders through appropriate communication channels.
Demonstrates strong written and verbal communication skills including the ability to translate complex technical concepts into clear regulatory justifications and to influence decisionmaking in crossfunctional and global forums.
Shows sound understanding of related technical disciplines (such as pharmaceutical manufacturing analytical testing quality assurance and quality systems) and applies this knowledge when defining regulatory strategies and compiling CMC dossiers.
Proven ability to identify regulatory risks and opportunities generate innovative yet compliant solutions to issues and collaborate effectively with internal and external partners to align on regulatory pathways.
Active participation in departmental and crossfunctional continuous improvement initiatives such as enhancement of templates processes systems; maintenance of standard operating procedures and internal guidelines etc.
Demonstrates flexibility and resilience in managing changing priorities unforeseen regulatory queries or health authority expectations and timesensitive projects while maintaining accuracy and compliance.
Exhibits strong leadership stakeholder management and interpersonal skills including mentoring junior colleagues and representing CMC regulatory function in project and governance meetings.

Qualifications we seek in you!

Minimum Qualifications
Bachelors or Masters degree required in Pharmacy Science or related field (advanced degree preferred)
Relevant years of global Regulatory CMC experience

Preferred Qualifications/ Skills

Possesses advanced working knowledge of MS Office
relevant regulatory/quality IT systems (e.g. document management RIMS and tracking tools) to efficiently prepare manage and archive CMC regulatory documentation.

Why join Genpact
Be a transformation leader Work at the cutting edge of AI automation and digital innovation
Make an impact Drive change for global enterprises and solve business challenges that matter
Accelerate your career Get hands-on experience mentorship and continuous learning opportunities
Work with the best Join 140000 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 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.