Associate Director - Regulatory Affairs - European Marketed Products
- Experience Level
Working as part of our evolving Regulatory Strategy and Agency Liaison group, this EU leadership role will combine technical project work, team management and commercial / departmental growth and development.
Reporting to the Head of Europe for Regulatory Strategy and Agency Liaison group, you will provide a regulatory strategic focus for lifecycle management including variations / amendments, renewals, line extensions / MAAs.
Additional responsibilities will include:
- Overseeing and executing all regulatory activities for assigned marketed product(s) including participation in the development of European regulatory strategies for the product lifecycle, from MAAs through to post-marketing
- Leading the regulatory working team and representing the team at project meetings and ensuring global regulatory lifecycle management strategy and submission planning are executed according to plan
- Responsibility for all CP, DCP, MRP and national submissions and approvals of project(s) of responsibility, or overseeing direct reports responsible
- Collaborating with the client lead, as needed, for the authoring of global regulatory strategies and ensuring critical deliverables as agreed within the global regulatory strategy and planning.
- Provides oversight to ensure regulatory compliance of Marketed Products, including oversight of the product-related data in the registration database
- At the request of the client, representing the client at Health Authority meetings for project(s)/product(s) of responsibility
- Collaborating with client stakeholders to identify the necessary regulatory requirements and establish the most appropriate course of action to meet project plans
- Leading a team of direct reports to support scope of project work, and identifying and addressing any development needs
- Serving as an expert in the field of European regulatory guidelines, sharing your knowledge with the team and addressing challenges when they arise
- Contributing to the development of departmental and organisational initiatives
- Contributing to the build-out of the team and department, including the development of branding materials and SOPs, and designing processes and procedures
- Providing European regulatory expertise for new business development opportunities or participating on due diligence teams, including attendance at bid defences, where requested.
This role offers exceptional scope for development and the opportunity to combine technical expertise with business acumen to contribute to this department’s growth.
Receptive to change, supportive and commercially-minded.
Here at PRA we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
- BSc degree (or equivalent) in a scientific discipline is essential
- Solid knowledge of regulations, policies, procedures, drug development guidelines and compliance for European countries
- Demonstrated track record of successful interactions with European health authorities related to post-marketed products
- Experience of managing relationships with clients and/or contractors.
- Able to manage risk and escalate issues when appropriate
- Previous experience in the functional management of a team of regulatory professionals is essential
- Excellent communication skills, both written and verbal, and the ability to collaborate with various internal and external stakeholders from around the world in a team-orientated environment
- Able to deal with issues of critical importance, provide regulatory advice and make reasoned decisions
Your health, your family, your career, your money — the things that matter to you, matter to us. The benefits of PRA just get better and better.
PRA Health Sciences is an Equal Opportunity Employer. We welcome and encourage diversity in the workplace.