My client, an expanding Clinical Research Organisation are currently seeking to recruit an Associate Director of Regulatory Affairs to join their Regulatory team. This position...
My client, a Global Pharmaceutical Company, has opened a new vacancy within their Regulatory team and are actively looking to recruit an EU Director Regulatory Policy and Intelligence. The role will be based at my client's offices in Central London.
The Senior Director/Director of EU Regulatory Policy & Intelligence is a leadership position that will drive the development and execution of Regulatory Policy agenda by providing EU regulatory policy expertise/input and maintaining/building relationships with EMA and key external stakeholders. Identifying EU regulatory policy trends occurring in the regulated environment that have the potential to impact on products and facilitate the adaptation of product strategies accordingly in order to enhance asset probability of success.
The Senior Director/Director of EU Regulatory Policy will actively engage externally to shape the EU policy environment in line with priorities. Will be responsible for partnering with key internal functions and relevant subject matter experts to set policy agenda and engage in direct EU regulatory advocacy activities.
- Provide senior management with position statements/talking points to: 1) influence evolving external environment and 2) establish the regulatory advocacy voice of the client.
- Identify and respond to EU regulatory/legislative policy issues that impact research, development and lifecycle management.
- Provide thought leadership in EU regulatory policy and maintain/develop mutually beneficial relationships with key leadership at Health Authorities and other external stakeholders.
- Drive the agenda through targeted participation on EU external committees and coalitions (i.e. major trade associations, public private partnerships, academia etc).
- Support EU regulatory affairs and product development with focused regulatory strategy derived from deep knowledge/understanding of regulatory external/competitive environment.
- Develop cross-functional communication and implementation plans to convey complex regulatory policy issues with impact to the business. Ensure external analysis is internalized to facilitate product strategy; track progress.
- This leadership role requires significant and independent interaction and influencing with senior management across the company.
- Due to the complexity and sensitivity of these needs, the incumbent must be able to demonstrate highly evolved strategic and influencing skills in interacting at all levels.
- Ability to work effectively and effortlessly in a highly collaborative and team oriented environment are essential components in this role.
Skills and Experience required:
- BSc. Advanced scientific related degree preferred Masters or PhD is preferred
- Extensive and relevant Regulatory / pharmaceutical experience
- Deep knowledge and experience with regulatory affairs and regulations in the EU.
- Successful NDA or BLA filing and approval experience; orphan/rare disease preferred.
- Demonstrable history of successfully serving in a leadership role either in, or working as a partner with, the EMA.
- Recognized expert in regulations, guidelines and precedents related to pharmaceutical development for small molecules or biologics.
- Deep understanding of the political environment and culture within the EMA/MHRA and the ability to identify key players to be engaged.
- Significant experience interacting with senior EMA/MHRA members at Divisional and policy levels; high level of credibility and respect within the EMA/MHRA.
If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589626
The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.