Regulatory Affairs Professional with CMC Expertise

Vor 2 Tagen

Frankfurt am Main, Hessen, Deutschland Genpact Vollzeit
Job Overview

We are seeking a highly skilled Regulatory Affairs Professional with expertise in Chemistry, Manufacturing and Controls (CMC) to join our team at Genpact.

About the Role

This is a dynamic opportunity to support a large client by filling in as a member of their team and handling regulatory submissions that may impact registrations of small molecules, biologics, and combination products. You will be responsible for providing scientific inputs and actively involved in RA CMC strategic discussions, leading cross-functional teams, and overseeing overall RA CMC activities.

Key Responsibilities
  • First point of contact for CLIENT CMC contact for any data/information with respect to the project
  • Provide scientific inputs and actively involved in RA CMC strategic discussions
  • Leads cross-functional teams at CLIENT
  • Responsible for overall RA CMC activities
  • Continuously monitor, improve, and adjust the needs of RA CMC team
  • Monitor assumptions, risks, and dependencies
  • Ensure timely tracking and reporting to CLIENT
  • On-going change management
  • Coordinate with RA CMC India resources on allocated tasks and ensure tasks are completed on time
  • Issue resolution; capturing feedback and complaints
  • Oversee planning of CMC regulatory changes and renewals
  • Provide regular progress reports and updates
Specific Tasks
  • Manage and oversee regulatory post-approval Chemistry, Manufacturing and Controls (CMC) changes involving deliverables such as:
  • Regulatory evaluation of change control (affected countries, data/documentation requirements per country, change category per country, and regulatory procedure per country) and regulatory strategy
  • Tracking list and review documentation
  • Dispatch final documentation package to Local Regulatory Affairs (LRA) in affected countries
  • Monitor timely submission and approval in affected countries
  • Manage and coordinate responses to health authority questions
  • Overall planning of all CMC regulatory changes per product together with relevant interfaces
  • Represent G CMC RA in cross-functional teams
Benefits and Qualifications
  • $120,000 - $180,000 per annum, depending on experience
  • Bachelor's degree required in Pharmaceutical Science, Engineering, or related field (advanced degree preferred)
  • At least 5 years in Regulatory Affair
  • Relevant experience in CMC tasks and related aspects
  • Demonstrated expertise managing Chemistry Manufacturing Control (CM&C) projects/products globally

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