Hobson Prior is currently recruiting for an EU Regulatory Affairs Manager based in Central London. The position is with a large pharmaceutical company who are determined to deliver pioneering medicines to enable better health for patients around the world.
- You will plan, manage and execute all regulatory activities of all levels of complexity for project of responsibility in development and/or supports regulatory activities for assigned marketed product of responsibility.
- Assure that all documents for regulatory applications are prepared in accordance with company SOPs, GCP and other guidelines.
- Partaking on project teams, providing regulatory support in the areas of clinical, non-clinical, Chemistry, Manufacturing and Controls and other related areas.
- Delivers a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- Represents as regulatory lead on the global development team for individual project of responsibility. (Can have multiple projects depending on development stage and complexity).
- Co-operates with all company regions to ensure a global regulatory strategy is created and executed upon for all projects within project of responsibility.
- Demonstrates problem-solving and interpersonal skills through effective interactions with team members and generates alternative solutions prior to elevation of issues to manager.
- Knowledge of team dynamics and ability to function as team leader.
- Ability to function with a good level of independence.
- Technical Leadership skills/understanding of managing people.
- BSc Degree, preferred however BA would be accepted.
- Good pharmaceutical industry experience coupled with sound regulatory experience or combination of solid regulatory and/or related experience.
- Experience as primary contact to regulatory authorities and in handling Agency meetings.
- Basic working knowledge of drug development process and regulatory requirements.
- Drug Development - understands the phases, processes and techniques used within a drug development environment including protocol design and development.
- Understands appropriate Competent Authority regulations and guidelines.
- Understand good clinical practices and can apply to a research environment.
- Working knowledge of Good Manufacturing Practices and Good Laboratory Practices as they apply to a pharmaceutical research and production environment.
- Applicable regulations, guidelines and regulatory processes.
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.