Senior Manager Regulatory Affairs-Publishing

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.

If you thrive in a fast-moving tech-driven environment love solving real-world problems and want to be part of a team thats 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 and on LinkedIn X YouTube and Facebook

Inviting applications for the role of Senior Manager Regulatory Affairs-Publishing

This role directly contributes to the Companys revenue growth and margin by leading operational teams in the Regulatory Space. Specifically the Senior Manager is required to :

Responsibilities

SME in Publishing and should lead the client front from Regulatory submission lead standpoint

Lead and deliver Regulatory Affairs advisory services including Sub Management M&A initiatives RIM remediation etc.

Define and build solutions for clients based on the scope of work

Work with Genpact sales to draft responses to RFPs

Build leadership connects & networks with global Regulatory leaders

Contribute to the organizations top line growth and profitability by ensuring that projects are delivered on time and within budget

Represent Genpact in governance meetings with clients and on oral presentations supporting new business

Represent Genpact at relevant conferences tradeshows and industry forums

Qualifications we seek in you!

Minimum Qualifications

Bachelors degree required in science engineering or related field

Experience in Regulatory Affairs either Strategy Information Management or Operations

A deep understanding of Life Sciences eco-system and the current market dynamics

Domain knowledge of regulatory requirements in a given region; multiple regions a plus

Prior experience running large scale RA projects within the industry

Proven project management skills

Robust communication and presentation skills

This position requires a self-motivated and organized individual with the ability to exercise flexibility decision-making maturity with problem solving and listening skills.

Internal drive work ethic and leadership skills.

Excellent communication and executive presence to connect at the C level.

Viewed as insightful creative articulate persuasive and organized.

Preferred Qualifications / Skills

Experience in Regulatory Strategy and / or Operations

Experience leading the execution of submissions for top pharma companies

Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines

Experience leading programs across multiple projects and clients

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.

Required Experience :

Senior Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1