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Associate – Regulatory Affair Opening At Genpact

SWARNALATHA B December 18, 2020

Genpact Recruitment 2020. Genpact Notification full detailes below. Genpact (NYSE: G) is a global professional services firm that makes business transformation real. We drive digital-led innovation and digitally-enabled intelligent operations for our clients, guided by our experience running thousands of processes primarily for Global Fortune 500 companies.

Important Vacancy details:

  1. Post Name: Associate – Regulatory Affair
  2. Qualification:Bachelor’s degree in pharma / Science
  3. Location:India-Mumbai
  4. Salary:NA
  5. Openings: NA

 Job Description: Hiring For Associate – Regulatory Affair  in Genpact!

The Role demands for a highly qualified professional who should have CMC experience under 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).
  • Proven ability to generate innovative solutions to problems and effectively work with and communicate to key partners.
  • Proven flexibility in responding to changing priorities or taking care of unexpected events.
  • Capability to handle multiple priorities and balance work to achieve business goals.

Minimum Qualifications

  • Bachelor’s degree in pharma / Science
  • Strong financial analytical skills and problem solving skills.
  • Effective communicate 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 working relationships with the team, peers and clients, scheduling flexibility required
  • Overall candidate should have decision-making, research and analytics approach and in numbers.
  • Good people and customer handling skills.
  • Effective communication and interpersonal skill.

Selection Process: The selection will be on the basis of Interview.

How to Apply : Click here for full details and Apply Online

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SWARNALATHA B

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