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.

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 anadvanced technology services and solutions company that deliverslastingvalue for leading ourdeep business knowledge operational excellence and cutting-edge solutions we help companies across industries get ahead and stay by curiosity courage and innovationour teamsimplementdata technology and AItocreate tomorrow to know us onLinkedInXYouTube andFacebook.

Inviting applications for the role of Lead Associate Publisher for US market - Regulatory Affairs- Operations

In this role You should be fresher or minimum years of experience and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent DocuBridge etc.

Responsibilities

The Role demands for an experienced Publisher with demonstrated ability to execute responsibility in a highly regulated & process driven environment the Person will be responsible for all the activities related to.

Submission Publishing and performing final technical quality review and technical validation (eCTD) for Canada and US submissions.

Should have knowledge about MAA NDS ANDS IND DMF NDA ANDA and BLA submissions e.g. Safety Submissions Annual reports OPDP submissions Protocol and amendment original application.

Notifying relevant stakeholders that the Submission is ready for approval

Dispatching submission to CESP EMA HC and US FDA.

Performing post-submission processing activities such as receiving acknowledgement from authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders.

Monitoring and reporting submissions activity such as reporting volume timelines and quality metrics; informing future planning and forecasting activities; supporting overall regulatory intelligence

Qualifications we seek in you!

Minimum Qualifications

Bachelors degree preferably in Pharmacy Medicine Chemistry or related Life science discipline required with relevant experience in the pharmaceutical industry.

Mandatory Knowledge of ICH FDA and EMA guidelines.

Working knowledge of eCTD / CTD / NEES types of submission industry standard publishing systems.

Should be advance level in English language.

In depth working knowledge of eCTD / CTD / NEES / Paper types of submission industry standard publishing systems.

In depth working knowledge of industry standard publishing systems and desktop applications.

Expertise with Publisher applications

Effective communication time management and organizational skills.

Technical Trouble shooting

Flexibility to adapt to a changing environment

Demonstrated project management and leadership skills.

Skilled at fostering customer relationships and driving collaboration.

Understanding of global regulatory processes and requirements.

Strong attention to detail ability to multi-task.

Expertise with industry standard electronic document management system

Preferred Qualifications / Skills

Key Attributes

Enthusiasm & confidence

Adhere to our principles and values.

Time Management skills.

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 :

IC

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