Manager, Regulatory Data

• - Perform operational activities for assigned elements of the regulatory information management process, XEVMPD, and the Global Product Registration List in accordance with quality control and quality improvement methodologies.
• - Act as a Data Steward for assigned regulatory data assets, maintaining and managing regulatory data as per the Enterprise Data Quality Framework.
• - Support the administration of regulatory data standards (XEVMPD, IDMP) and the processes used to govern the collection, coding, analysis, and quality control of regulatory information.
• - Compile and deliver XEVMPD or other regulatory information-based submissions to health authorities.
• - Develop expertise in critical topic areas such as technical skills (XEVMPD, IDMP), knowledge of international regulations, and other skills (communication, project management).
• - Support changes based on intelligence about the regulatory environment and changes related to regulatory information practices. Provide operational support for new or optimized business processes to match environmental changes.
• - Support continuous improvement initiatives.
• - Prepare business reports, analyses, or alerts in response to business needs or health authority requests.
• - Ensure collection and coding of regulatory information is done in compliance with regulatory and pharmacovigilance legislation, regulatory processes, and regulatory data standards. Review results of audits to ensure accuracy and compliance with regulations and procedures.

Essential Skills/Experience:

• - University degree in the life sciences
• - Experience in pharmaceutical/medical industry
• - Strong analytical and critical thinking ability
• - Knowledge of pharmaceutical drug development process
• - Good understanding of current regulatory legislation, guidelines, and trends relating to regulatory information management (process, tools, standards)

Desirable Skills/Experience:

• - Manages change with a positive approach to the challenges of change for self, team, and the business. Sees change as an opportunity to improve performance and add value to the business.
• - Excellent written and verbal communication skills, negotiation, collaboration, and interpersonal skills.
• - Good problem and conflict resolution skills.
• - Demonstrated ability to set and manage priorities, resources, performance targets, and project initiatives in a global and regional environment.
• - Ability to thrive in a rapid-paced environment.