Genpact Assistant Manager - Regulatory Affairs Bachelor's
degree required in science, engineering or related field
Responsibilities:
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.
Demonstrated effective leadership, communication,
and interpersonal skills.
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