Randstad
Location
Madhya Pradesh | India
Job description
• Lead project management for the submission team by setting direction, escalating issues,
establishing project management team R&R (roles and responsibilities) besides leading
or delegating detailed submission planning.
• Assess project risks and lead stakeholder discussions with respect to regulatory
submissions. Develop and lead relevant templates for submission completeness while
continuously monitoring progress and creating relevant reports for the management
team
• Lead scenario discussions for impact of regulatory strategies.
• Facilitate issue identification and resolution, problem-solving, risk management,
contingency planning, and decision-making.
• Proactively identify CMC critical path, risks and impediments to successful development
and drive the identification and development of solutions to mitigate the risks.
• Support or conduct meetings essential to submission success such asthe Kick-Off meeting
and Submission Working Group.
• Create or delegate the creation of a detailed project plan commensurate with scope in an
appropriate planning tool to closely manage the critical path and associated analytics.
• Facilitate the development of indication specific submission content.
• Ensure the development and tracking of key messages.
• Create and maintain the regulatory components to an overall integrated project plan
• Manage regulatory information, documentation, and team communications to ensure
timely and accurate dissemination of the RA strategy and operational status throughout
Job tags
Salary
