Manager - Regulatory Affairs
Genpact
5 - 10 years
Mumbai
Posted: 06/06/2025
Job Description
Responsibilities
Able to understand the basics of a new system and process, the clients way of working, and the training strategy
Develop and deliver training materials per clients 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, clients 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:
Bachelors or Masters 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
About Company
Genpact is a global professional services firm that offers a wide range of digital transformation services and solutions. With a presence in over 30 countries, Genpact leverages its deep domain expertise in operations and analytics to help businesses transform their operations, improve efficiency, and enhance customer experience. The company combines digital technology, data science, and operational excellence to deliver business outcomes across various industries, including banking, insurance, manufacturing, and healthcare. Founded in 1997 as a subsidiary of GE, Genpact has grown into an independent, NYSE-listed company with a diverse workforce of over 90,000 employees globally.
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