Genpact Hiring Lead Associate - Regulatory Affairs Bachelor’s degree in pharma / Science Apply Now
Lead
Associate - Regulatory Affairs-CPG020139
With
a startup spirit and 90,000+ curious and courageous minds, we have the
expertise to go deep with the world’s biggest brands—and we have fun doing it.
Now, we’re calling all you rule-breakers and risk-takers who see the world
differently, and are bold enough to reinvent it. Come, transform with us.
Are you
the one we are looking for?
We
are inviting applications for the role of Lead 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.
Responsibilities
The
Role demands for a highly qualified professional who should have CMC experience
under regulatory affairs domain. Lead Associate 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.
TO APPLY CLICK HERE
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