Regulatory Affairs Lead
2 weeks ago
Our Culture
At Sobi, we refuse to accept the status quo and strive to create solutions that serve the needs of those affected by rare diseases.
Job Details
The Global Regulatory Compliance Lead will lead Regulatory Compliance activities, including procedural document creation and updates, audit and inspection execution and preparation, and regulatory risk management.
Responsibilities:
- Lead assigned Regulatory Compliance work and improvement activities
- 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.
- Manage parts of onboarding and exit activities for employees and consultants in relation to training.
- Lead procedural documents creation and updates, involving regulatory and cross-functional SMEs.
- Act as Global Process Owner for assigned procedures.
- Lead preparations and execution of audit and inspection activities as relevant for regulatory.
- Follow up on change control, deviations and continuous improvement activities.
- PSMF responsible within Global Regulatory Affairs.
- Escalate any compliance and/or quality risk internally
- Support regulatory compliance activities in acquisitions and integrations.
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