Coordinate, prioritize and track regulatory activities and submissions associated with the company's development and post-marketing activities.
25th June, 2019
Responsible for the coordination, prioritization and tracking of regulatory activities and submissions associated with the company’s development and post-marketing activities.
Resolve project issues by managing contingency planning and influencing risk mitigation strategies with input from various functions.
Develop and maintain high level and detailed timelines that utilize project management software tools, with input from the functional leads, assuring that the functional timelines are aligned with global program timelines.
Track functional milestones (CMC, Clinical, Nonclinical, Regulatory, ROW) and other sub-team activities to ensure overall adherence to the project timeline. Bring issues to the Project Team leader’s or other individual’s attention when necessary and participate in the resolution of delays or potential delays.
Manage regulatory team operations, including facilitation of team and strategy meetings (schedule, prepare/distribute documentation and ensure action item follow-up; meeting leadership often required).
Act as a conduit of information and maintain strong collaborations between assigned cross-functional submission teams and the Regulatory Project Team.
Support and assist in the development, implementation and continuous improvement of PMO tools and processes for regulatory project management of new product licensures and lifecycle project management for existing products.
Respond to changing duties as responsibilities may vary based on potential pipeline growth, project needs, and stages of development (pre-clinical, clinical or commercial).
May be supervising junior staff (FTE or contract)
Technical Requirements & Skills:
Required Bachelor of Science degree with minimum of 10 years in the biotechnology or pharmaceutical industry, 5 years’ direct experience in regulatory affairs preferred.
Advanced knowledge of drug development process, global regulatory process, and business requirements.
Outstanding Project Management skills, including expertise in designing, developing, and managing project schedules and resource management.
Logical and structured approach to planning and problem solving and decision-making.
Ability to anticipate issues and aggressively drive initiatives to achieve results.
Excellent interpersonal skills; adept at working as a part of an interdisciplinary team and skilled at negotiation and influencing others.
Willingness to work collaboratively, think critically, and incorporate diverse perspectives into decision-making.
Demonstrated ability to work successfully in a nimble, fast-paced matrixed environment.