Oxford Global Resources are looking for a Regulatory Affairs Specialist for a very interesting professional opportunity in Madrid.
- Compile, write, review and publish registration dossiers for new product registrations by applying solid international regulatory knowledge and CMC expertise.
- Collaborate effectively with internal partners and global clients for the maintenance of marketing authorizations of all out-licensing activities.
- Consolidate authorized dossiers and perform regulatory activities to ensure regulatory compliance.
- Coordinate working groups for the effective response to deficiency comments from international regulatory agencies and author response documents with support from working groups.
- Provide regulatory support and insight to internal and external partners.
- Collaborate with service providers and coordinate activities with internal/external
- partners to meet regulatory objectives.
- Maintain regulatory database on a daily basis.
- Coach other junior regulatory specialists in the department.
- Participate in product development activities and periodic meetings with upper management.
- Solid CMC expertise gained from international registration of new products. (Please kindly refrain from applying to this position if this requirement is not met).
- Strong project manager (experienced in the initiation, planning, execution, control and closing of projects) with the ability to multi-task to deliver high-quality regulatory work products on time.
- Highly efficient team player who excels in a fast-paced environment.
- Possession of strategic outlook based on a deep understanding of the product life cycle and its relationship with regulatory affairs.
- Organized and meticulous professional who is a self-starter and autonomous.
What we offer:
- An exciting and fast-paced working environment with ample opportunity for professional and personal growth.
- An opportunity to be an integral part of a growing team where an impact can be made.
- Positive working environment based on collaboration, integrity, knowledge acquisition and knowledge sharing, transparency and effectiveness.
- Be part of a horizontal organization that is managed based on the principles of