EU Regulatory Science Lead - Neurology
EU Regulatory Science Lead - Neurology
UCB - Union Chimique Belge
Brussels, Belgium
About the role
The Therapeutic Area Regulatory Science Lead is a highly driven and seasoned proactive leader with line as well as matrix management experience. The person is responsible for all regulatory strategic and operational activities related to product development and marketing authorizations in the region for a range of products. The person is the primary contact point within UCB for any regulatory issues for the therapeutic area in the region and, as needed, is a liaison with designated health authorities.
Who you’ll work with
The person reports into the Head of Regulatory Affairs Europe and is part of the regional as well as extended Global Regulatory Affairs leadership team.
What you’ll do
- Lead a team of Regulatory Scientists & Regulatory Science Leads;
- Oversees the development and implementation of the regional regulatory strategy, consistent with the business objectives, in putting regional expertise into the global regulatory strategy and global planning in collaboration with the Global Regulatory Leads of the therapeutic area and the centre of excellence lead;
- Manages a team of direct reports that are regulatory leads for products/indications in the therapy areas for the region;
- May in addition function as Regulatory Science Lead for products depending on development activities and UCB priorities as assigned by the Head of European Regulatory Affairs. Coordinates the regional submission team, as needed. Similarly, may be the primary point of contact for health authorities for products as assigned by the Head of European Regulatory Affairs;
- Responsible for developing, directing, and overseeing training of respective therapy area regional regulatory team members. Coaches and mentors team members and provides guidance and development opportunities;
- Serves as the primary regional point of contact for global regulatory asset leads, centre of excellence leads, regional commercial, medical and market access leads.
Interested? For this position you’ll need the following education, experience and skills:
- Bachelor’s degree required, preferably in a scientific field. Master’s preferred;
- Significant pharmaceutical experience in Regulatory Affairs, preferably within the therapeutic area and region, working with cross-functional and international teams and with knowledge and experience of regional regulatory procedures and legislation related to two or more of the following: drug development, product registration, line extension or license maintenance;
- Strongly desired experience:
- Leading, training, and developing teams.
- Developing and defending integrated strategic product development plans
- Developing strategic regional labelling to maximize asset opportunity based on current science and data and in collaboration with the Global Labelling Leads and regional labelling lead.
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