Full-Time Global Regulatory Compliance Lead

The Global Regulatory Compliance Lead is responsible for leading assigned Regulatory Compliance activities, including but not limited to activities related to the procedural document creation and updates, audit and inspection execution and preparation and regulatory risk management.

The role will also support the Global Regulatory Affairs department with various operational quality and compliance activities, as well as training assignments and follow-up.

This position will be within Global Regulatory Affairs (GRA) and will report to the Head of Compliance, Business Operations.

This is a remote position - candidates located in Sweden are preferred.

Key Responsibilities:

1. Lead assigned Regulatory Compliance work and improvement activities
2. Act as Quality Training Contributor (QTC) for the department: manage GRA training curricula and Learner Roles, assignment of training to GRA, follow up on training compliance and 1st line support in Veeva Quality for GRA
3. Manage parts of onboarding- and exit activities for employees and consultants in relation to training
4. Lead procedural documents creation and updates, involving regulatory and cross-functional SMEs
5. Act as Global Process Owner for assigned procedures
6. Manage GRA Business Contingency Plan responsibilities
7. Lead preparations and execution of audit and inspection activities as relevant for regulatory
8. Follow up on change control, deviations and continuous improvement activities
9. PSMF responsible within Global Regulatory Affairs
10. Escalate any compliance and/or quality risk internally
11. Support regulatory compliance activities in acquisitions and integrations

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