Senior Manager - Regulatory Affairs Job in Genpact

Responsibilities

• Perform document level & submission level publishing, assembly and distribution activities.
• Performing submission readiness checks.
• Compiling SAS and other datasets and non-PDF files.
• Publishing documents for eCTD, NeeS, paper, and other PDF format submissions.
• Performing final technical quality review and technical validation (eCTD/NeeS)
• In depth solid understanding of ECTD/ NEES types of submission, industry standard publishing systems.
• Effective time management and interpersonal skills to efficiently run multiple time-sensitive assignments simultaneously
• Demonstrates deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high quality deliverables
• Demonstrates the ability to independently solve trouble shoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
• Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation
• Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures

Minimum Qualifications

• Bachelors 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, problem solving skills
• Ability to balance customer governance meetings

Preferred qualifications

• 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.