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
- 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
- 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.
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