A newly created position is on offer for a highly experienced regulatory professional to set up and lead the Regulatory Intelligence function for a globally recognised Biotech. Reporting to the VP of EU RA, this is a role of high autonomy and you will have significant influence on the operation of the department moving forward.
A background in Regulatory Intelligence is no necessary but you must have an intimate knowledge of the EU regulatory framework particularly in regards to clinical development.
Key responsibilities:
- Monitors the European regulatory environment and other geographies for changes that potentially impact the business and works closely with government affairs in this context.
- Timely prepares executive summaries of new guidelines/directives/policies or delegates such preparation to other regulatory staff.
- Proactively meets with appointed representatives of affected functional areas to assess the impact of new guidelines/directives/policies, decide whether the organization should submit comments on the new guidelines/directives/policies, determine most impactful mechanism for submitting comments, develop an action plan for addressing needed changes to SOPs/work practices, develop a plan for communicating the impact of the new guidelines/directives/policy throughout the organization.
- Actively participate in industry and professional organizations.
- Provides ongoing information to the organization about changes to the global regulatory environment.
Key deliverables of the position are clear communication of the impact of regulatory changes within the organization, modification or institution of internal work practices in compliance with changing regulatory requirements, positive relationships with worldwide regulatory authorities, and a leadership role for the company within industry organizations.
An outstanding salary and benefits package is on offer for the right candidate.
A full job description is available upon request.
This job was posted 30+ days ago, and has expired.
