Genpact Pharma Lead Consultant Vacancy - Regulatory Affairs

Genpact Pharma Lead Consultant Vacancy – Regulatory Affairs

Genpact announces job opening for pharma candidates. B pharma job opening 2022. Regulatory affairs job opening 2022. Pharma Lead Consultant vacancy 2022, B Pharma job opening 2022, Pharmacy job opening 2022, Intrested and eligible candidates may check out all the details on the same below:

Job Title: DG – Lead Consultant – Regulatory Affairs-CPG020910

Eligibility Criteria:

  • Bachelor’s degree in pharma / Science
  • Strong financial analytical skills and problem-solving skills.
  • Effective communication in writing and verbally to senior management.
  • Experience in balancing customer-facing role and work assessments.
  • Self-starter and have analytical, prioritization skills
  • Ability to balance customer governance meetings

Preferred qualifications

  • Able to further robust working relationships with the team, peers, and clients, scheduling flexibility required
  • Overall candidate should have decision-making, macro-level research, and analytics approach and be good in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skills.


The Role demands a highly qualified professional who should have CMC experience in the regulatory affairs domain. BA will be responsible for all the activities related to –

  • Provide input to project regulatory strategies by performing assessments of CMC changes, identifying global regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks.
  • Execute regulatory strategies by leading the development, authoring, and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions per established business processes and systems.
  • Collaborate closely with MMD and partners to support compliant execution of organizational change and conduct all activities with an unwavering focus on regulatory conformance.
  • Assess and communicate potential regulatory risks and propose mitigation strategies.
  • Deliver all regulatory results for assigned products across the product lifecycle
  • Identify and communicate potential regulatory issues to GRACS CMC, as needed
    Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
  • Demonstrated ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
  • Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.

Apply Online

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