Genpact Hiring Lead Associate - Regulatory Affairs Bachelor’s degree in pharma / Science Apply Now
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.
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 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 good in numbers.
Good
people and customer handling skills.
Effective
communication and interpersonal skill.
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