Associate Director Regulatory Processes & Compliance
AIXIAL is an International Contract Research Organization (CRO), a member of the ALTEN Group, providing complex services in clinical trials (phase I-IV) and non-interventional studies. Our offices are located in France, Belgium, Switzerland, Germany, Scandinavia and Czech Republic.
We are currently looking for an experienced Associate Director Regulatory Processes & Compliance to take responsibility for the management of assigned projects, processes including implementation, communication, compliance, performance and inspection readiness. Accountable to develop relationships across Regulatory Affairs and other relevant areas to execute the delivery of the processes strategy.
The activities include (but are not limited to):
- Support authoring and Project Management of procedural document such as Standard Operating Procedures, Work Instructions and Best Practice documentation
- Identify opportunities for and drives the enhancement of existing processes through knowledge of internal and external environment.
- Working with the Process Directors, and Patient Safety and Regulatory experts, develop, establish, monitor, report and assess global KPIs related to safety and regulatory data reporting.
- Maintain and support the global inspection readiness strategy.
- Provide process or compliance support to regulatory teams and submissions.
- Identify opportunities to improve and simplify the methodology in processes and guidance, provide practical solutions and drive to implementation.
- Identify and promote innovation and new ways of working, identify issues and risks and propose options to mitigate them.
- Support activities required to prepare for or in response to for GVP, GCP, GRP and GMP audits/inspections.
- Provide process training to relevant functional groups.
- A science/pharmacy/nursing degree, with at least 5 years relevant experience (pharmaceutical, regulatory, safety and partnership).
- Thorough scientific knowledge sufficient to understand all aspects of regulatory/pharmacovigilance and partnership issues.
- Experience of working in cross-functionally setting, preferably in a global organization.
- Excellent written and verbal communication skills in English, preferably worked with writing SOPs.
- Knowledge of new and developing regulatory and pharmacovigilance expectations