Sr. Specialist - Regulatory Affairs - Operations 4D

Sr. 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 

• Able to understand the basics of a new system and process, the client’s way of working, and the training strategy 

• Develop and deliver training materials per client’s requirements while ensuring compliance 

• To be able to handle various platforms, namely Learning Management Systems (Veeva Vault Training, Cornerstone OnDemand) for training delivery, content development tools (Articulate 360, Adobe Captivate), SOP and Document Management Systems (Documentum), Assessment and Evaluation tools (Google Forms & Microsoft Forms), Virtual Training and Collaboration Tools (Microsoft Teams, Zoom, Webex Training) 

• To be able to collect and document the training and SOP aspects discussed in the focus topics 

• Assign content to the correct training module (functional vs. process, training vs. SOP) 

• Collaborate with different departments to identify training needs, gaps, and raise questions in case of unclarities 

• Update training materials as per the feedback received from SMEs 

• Develop, review, and update SOPs to comply with regulatory standards 

• Develop Work Instructions and Handouts as per industry best practices 

• Ensure training and SOPs are written clearly and in compliance with the language 

• Manage the SOP lifecycle, version control, approvals, and periodic reviews 

• Ensure all users are trained on the new and updated training materials & SOP in timely manner 

• Knowledge of GMP, GCP, GLP, and Pharmaceutical Regulation (EMA, ICH, FDA, etc.) is required 

• Strong experience with LMS, RIMS, and DMS systems is necessary. 

General tasks: 

• Understand new systems, processes, client’s way of working, and training strategy. 

• Develop and deliver compliant training materials per client requirements. 

• Handle platforms for training delivery, content development, SOP and document management, assessment and evaluation, and virtual training and collaboration. 

• Document training and SOP aspects discussed in focus topics. 

Experience: 

• Bachelor’s or Master’s degree in Pharmaceutical, Computer Science, IT, Engineering, or a related field. 

• 10+ years of experience in Computer System Validation (CSV) in the pharmaceutical, biotech, or medical device industry. 

• Strong knowledge of GxP, 21 CFR Part 11, GAMP 5, Data Integrity, and Annex 11. 

• Experience in validating SaaS applications used in the pharmaceutical industry. 

• Familiarity with Veeva Vault RIMS, QualityDocs, or Submissions Archive is a plus. 

• Excellent documentation skills and experience with validation lifecycle documentation. 

• Ability to work independently and collaborate with cross-functional teams. 

Qualification: 

• Atleast Bachelor's degree required  in for Pharmaceutical: science, engineering, or related field (advanced degree preferred). 

• Veeva Vault RIM certification is a plus. 

• Experience working in an Agile/Scrum environment 

Language:  English 

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 Compliance Manager (CRCM) - The International Association of Risk and Compliance Professionals (IARCP)The International Association of Risk and Compliance Professionals (IARCP)

Required Skills -

People Leadership, Personal Effectiveness

Language

English (Required)

Language Proficiency -

Proficient - C2

Additional Job Location -

Job Type

Regular

Master Skill List -

Regulatory Affairs - Operations

Remote Type -

Hybrid

Work Shift -

With shift (Romania)

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.