Genpact Hiring Technical 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.
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