Genpact Regulatory Technical Associate Vacancy – Apply Online
They are inviting applications for the role of Technical Associate, Regulatory affairs! In this role, you will be responsible to work on deadlines, in a fairly high-pressure business environment while being a good team member. You should have the ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
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Job Title: Technical Associate – Regulatory Affair-CPG020636
- The Role demands for a highly qualified professional who should have CMC experience under 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).
- 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.
- 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 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 skills.
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