Regulatory Affairs at Genpact | Chemistry Graduates Apply Now
Are you looking for Regulatory Affairs Jobs with a global organization that is shaping the future through AI and digital innovation? Genpact careers offer an exciting opportunity for freshers and professionals to build a strong foundation in regulatory operations while working with cutting-edge technologies and global clients in a fast-paced environment.
About Genpact
Genpact is a global leader in advanced technology services and solutions, helping businesses transform through data, AI, and digital innovation. With a strong presence worldwide and over 140,000 professionals, Genpact careers provide long-term growth, learning, and impactful work across industries. If you are searching for Genpact Jobs in Regulatory Affairs, this opportunity offers the perfect blend of innovation, compliance, and career advancement.
Inviting Applications for the Role of Technical Associate, Publisher for the US Market – Regulatory Affairs- Operations
In this role, you should be fresher or have a minimum of years of experience, and have good knowledge of ICH guidelines and CTD Structure & Expertise with Publishing Tools like Liquent, DocuBridge, etc.
Responsibilities
In this role, you will be responsible for:
- The Role demands for a 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.
- Publishing and performing technical validation of eCTD for US submissions.
- Performing final technical quality review.
- Dispatching submission to the relevant authority (eCTD/CTD/NeeS/Paper) or affiliate so that the affiliate can dispatch to the authority.
- Performing post-submission processing activities such as receiving acknowledgement from the authority of submission receipt; capturing and the electronic receipt and metadata in RIM; communicating submission receipt to key stakeholders.
- Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments, and metadata.
Qualifications We Seek in You!
Minimum Qualifications
- Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or a related Life science discipline, required with relevant experience in the pharmaceutical industry.
- Mandatory Knowledge of ICH and FDA guidelines for the US market.
- Working knowledge of eCTD/ CTD/NEES types of submission, industry standard publishing systems.
- Should be at an advanced level in the English language.
- In-depth working knowledge of eCTD/CTD/NEES/Paper types of submission, industry standard publishing systems.
- Effective time management and organizational skills.
- Effective communication.
- Flexibility to adapt to a changing environment.
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 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 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.
Job Technical Associate
- Primary Location: India-Mumbai
- Schedule: Full-time
- Education Level: Bachelor’s / Graduation / Equivalent
- Unposting Date: Ongoing
- Master Skills List: Operations
- Job Category: Full Time
