Job Description

Vacancy for Senior Manager – Chemical Regulatory at Genpact Limited.

Job Title/Position:

Senior Manager – Chemical Regulatory-CPG018889

Job Overview:

Job vacancy for Pharmacy, Science

Job Location:

Mumbai

What are the Key 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.

What are the Educational Qualification(s) for this position(s)?

B.Pham, B.Sc

What are the Preferred Skills required for this Job/Position?

• 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, problem solving skills
• Ability to balance customer governance meetings
• Able to nurture robust working relationships with the team, peers and clients, scheduling flexibility required
• Overall candidate should have problem solving, macro-level research and analytics approach and good in numbers.
• Good people and customer handling skills.
• Effective communication and interpersonal skill.

Opportunities at CSIR- Central Drug Research Institute

Detailed notice

https://genpact.taleo.net/careersection/sgy_external_career_section/jobdetail.ftl?job=775141

Vacancy for Senior Manager – Chemical Regulatory at Genpact Limited