Manager - Regulatory Affairs

Genpact (NYSE: G) is a global professional services and solutions firm delivering outcomes that shape the future. Our 125,000 people across 30 countries are driven by our innate curiosity, entrepreneurial agility, and desire to create lasting value for clients. Powered by our purpose - the relentless pursuit of a world that works better for people - we serve and transform leading enterprises, including the Fortune Global 500, with our deep business and industry knowledge, digital operations services, and expertise in data, technology, and AI.

Inviting applications for the role of Manager - Training and SoP Author Lead, Regulatory
We are looking for a Training and SoP Author Specialist with experience in the Life Sciences pharmaceutical industry to ensure compliance with regulatory requirements, including 21 CFR Part 11, GxP, and Annex 11. The ideal candidate should have expertise in Regulatory Information Management applications, with a strong understanding of Veeva Vault RIMS being a plus.
Responsibilities
. Able to understand the basics of a new system and process, the client&rsquos way of working, and the training strategy
. Develop and deliver training materials per client&rsquos 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&rsquos 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&rsquos or Master&rsquos degree in Pharmaceutical, Computer Science, IT, Engineering, or a related field.
. Moe 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

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 diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit . Follow us on Twitter, Facebook, LinkedIn, and YouTube.
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