Direct, oversee and manage complex regulatory projects, ensuring quality deliverables on time and within budget. Ensure that all project work is completed in accordance with SOPs, policies and practices.
RESPONSIBILITIESMay act as a Project Manager for a large stand-alone programme, involving several regulatory or technical deliverablesand/or region, and/or operation. Undertakes risk analysis, management and contingency plans, as appropriate.
•Provides strategic regulatory and/or technical consultancy on a variety of projects, internally and externally, usinginnovative solutions where appropriate.
•May manage meetings with Regulatory Agencies.
•May write and/or review a complete single service regulatory proposal and defend costs and timelines to clients.
•Provides mentorship to junior colleagues and advise others on many regulatory document types.
•May plan and deliver workshops or presentations on Regulatory Affairs topics for conferences or publications.
•May be assigned as Reviewer and/or Approver for Regulatory SOPs or cross-functional SOPs owned by other operations.
•May support global regulatory or technical initiatives or act as a regional representative on a cross-functional initiative.
•Performs other tasks or assignments, as delegated by Regulatory management.
All responsibilities are essential job functions unless noted as nonessential (N).
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
- Extensive experience in regulatory and/or technical writing
- Advanced negotiating and influencing skills and the ability to identify and resolve issues, using flexible adaptable approach. Remains calm, assertive and diplomatic in challenging interactions with customers
- Strong software and computer skills, including MS Office applications
- Acts as a role model to junior colleagues; possesses a positive attitude and communication style to customers and colleagues. Communicates effectively with all levels of the organization and remains motivated and enthusiastic in times of change and other pressure situations
- Ability to exercise independent judgement taking calculated risks when making decisions
MINIMUM REQUIRED EDUCATION AND EXPERIENCE Degree in life science-related discipline or professional equivalent plus at least 8 years relevant experience* including6 years regulatory experience (*or combination of education, training and experience)
Extensive use of telephone and face-to-face communication requiring accurate perception of speech
Extensive use of keyboard requiring repetitive motion of fingers
Regular sitting for extended periods of time
Travel will be required