Responsibilities include but not limited to the following:
- Maintain technology roadmap to support Global Regulatory Operations
- Lead process and system improvements that will drive greater effectiveness and efficiencies
- In collaboration with stakeholders develop business case for desired technology and process improvements
- Ensure proper maintenance, improvement and development of validated systems that support regulatory processes
- Monitor and provide insight into new requirements/guidance relevant to regulatory operations
- Evaluates emerging regulations and changing regulations for impact on
- Inter-dependent partnering skills, highly team-orientated and demonstrable
- Ensures compliance with SOPs and WPs. Supports or leads development of new SOPs, WPs, or best practices for regulatory operations either for regional needs or global regulatory.

Qualifications
Skills/Knowledge Required
- Bachelor’s degree in appropriate discipline; Advanced degree preferred;or equivalent experience.
- At least 10 years experience in Regulatory Affairs/Operations
- Demonstrated Leadership ability and prior experience in global regulatory operations position with pharmaceutical industry
- Thorough knowledge and practical experience in global submissions and systems
- Experience managing staff
- Experience in Global Regulatory Operations and related areas.
- Experience managing large scale technology projects (e.g. EDMS, eCTD publishing tools, tracking systems, etc.)
- Experience with global eCTD structure and requirements.
- Experience with electronic document management software and principles of information systems
- Must demonstrate critical thinking, risk assessment and judgment
- Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously