Regulatory Affairs Project Manager

3 days ago

Wokingham, United Kingdom PE Global Full time

**PE Global is currently recruiting for a Regulatory Affairs Manager for a leading multi-national pharmaceutical client based in Wokingham.**

**Role**:

- Utilizing the expertise within the Regulatory organization, develops and co-ordinates execution of the strategies for the program to align with expectations.
- Drives consistency across all platforms across Medical Devices for technical documentation creation and adherence to procedures.
- Develops and maintains constructive and cooperative working relationships with business functions in the organization.
- Establishes and leads regulatory objectives to identify and deliver all required regulatory project activities.
- Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule and resource model.
- Working across the businesses and franchises, develops solutions and aligns on regulatory strategies with an emphasis on an ability to work with SMEs in labelling, quality and regulatory compliance.
- Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges and process improvements throughout the program.
- Identifies and facilitates continuous improvement activities.
- Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams.
- Educates franchise Associates on UK regulations and requirements and integrating those requirements into franchise shared procedures.
- Responsible for communicating business related issues or opportunities to next management level.
- Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition.
- Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
- Performs other duties assigned as needed.

**Requirements**:

- Bachelor’s degree with 5-8 years of experience or PhD, Pharm, Masters, legal degree with adequate experience required. Advanced degrees and education in medicine, engineering, science or law preferred.
- Adequate experience in EU regulatory requirements for medical devices required.
- Experience of managing Projects with team members in several different locations, acted as a PMO
- Travel: Up to 10% travel may be required

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