Specialist - Regulatory Affairs - Operations 4A

Specialist - Regulatory Affairs - Operations

Ready to turn bold ideas into real-world impact?
 At Genpact, we don’t just adapt to change, we lead it. AI and digital innovation are transforming the way businesses work, and we’re at the forefront of it. Genpact’s AI Gigafactory, our industry-first accelerator, exemplifies how we scale advanced technology solutions to help global enterprises work smarter, grow faster, and transform at scale. Whether tackling complex challenges through large-scale models or 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 what’s possible, this is your moment. 
 
Genpact (NYSE: G) is an agentic and advanced technology solutions company. We leverage process intelligence and artificial intelligence to deliver measurable outcomes. With a strong partner ecosystem and decades of client trust, we provide innovative solutions that transform how businesses run. Powered by a team with an active learning mindset and client centricity at its core, we deliver lasting value for the world’s leading enterprises.
 Get to know us at genpact.com and on LinkedIn, YouTube, X, and Facebook.

Job Description

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 affiliate can dispatch to authority. 

• 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. 

• Capturing submissions-related correspondence from health authorities, such as uploading documentation, commitments and metadata. 

Requirements 

• Bachelor’s degree, preferably in Pharmacy, Medicine, Chemistry, or related Life science discipline required with relevant experience in the pharmaceutical industry.  

• Mandatory Knowledge of ICH and FDA guideline for US market.   

• 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. 

• Effective time management and organizational skills. 

• Effective communication. 

• Flexibility to adapt to a changing environment. 

Key Attributes 

• Enthusiasm & confidence  

• Adhere to our principles and values. 

• Time Management skills. 

Qualifications

Bachelors - Health Administration, Bachelors - Healthcare, Bachelors - Pharmacy, Masters - Public Health, Masters - Regulatory Affairs

Certifications

Certified Compliance Officer (CCO) - VskillsVskills, Certified Public Accountant (CPA) - Perfekt SzolnokPerfekt Szolnok, Certified Regulatory and Compliance Professional (CRCP) - JSS UniversityJSS University, Certified Regulatory Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills

Publishing, Regulatory Affairs Management, Regulatory Submissions

Language

English (Required)

Language Proficiency -

Upper Intermediate - B2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Remote

Work Shift -

Day Job (Costa Rica)

Why join Genpact?
•    Lead AI-powered transformation – Drive innovation and solve real-world business challenges that matter
•    Make an impact – Help global enterprises solve business challenges that matter 
•    Accelerate your career – Gain hands-on experience, mentorship, and world-class learning opportunities to stay ahead
•    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 140,000+ coders, 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.