Lead Consultant, Regulatory Affairs!

Responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidance and defined regulatory strategies along with the preparation and review of information required for development of regulatory CMC dossiers for commercial products.

Work on authoring CMC documentation for worldwide marketing of pharmaceutical products for initial registration and life-cycle management under direction of team scientists.

Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.

Able to prioritize & execute the project according to the project plan/timelines/schedules.

Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders using different communication channels.

Understanding of job responsibilities & processes of cross-functional teams, manufacturing sites, Quality Assurance, Quality control, etc. Prior experience in these departments is preferable.

Experience in RA/ QA/ QC system and tools like SAP, documentum, Veeva, LIMS, spotfire, Power BI, etc is preferrable.

Demonstrated oral and written communication skills and the ability to communicate issues in a succinct and logical manner. Strong listening skills.

Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

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.