Genpact Hiring Associate - Regulatory Affair 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).
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
Join for Regular Job Updates in What's App & Telegram
No comments:
Post a Comment