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Regulatory Affairs Registration Manager - Belgium
Keyrus Biopharma (company)
Posted on : 12 June 2017
- We are looking for an experienced professional specialized in Regulatory Affairs for a consulting position of Senior Regulatory Affairs Registration Manager.
The job purpose is to give support for registration activities mainly at international level, to upgrade the licenses and registration dossiers and to align with the most updated EU Licenses.
Role and main tasks:
- General understanding of the entire Client's portfolio and regulatory framework
- Understand and review the current gap analysis of specific licenses at international level
- Re-initiate discussions with LOC's, understand current regulatory status and local requirements, and discuss submission regulatory strategy
- Engage with other Regulatory Affairs departments and other relevant stakeholders to coordinate/deliver the regulatory packages
- Review the planning into the Client's tool and ensure cleaning/updating appropriately
- Training on tools
- Ensure documentation/correspondence is appropriately archived
- Link with Regulatory Affairs team dedicated to publishing
- Input/support other Regulatory Affairs teams
- Follow up with LOC's on new activities such as labelling variation,....
- Scientific (University Degree)
- Regulatory background
- Regulatory environment / procedures (including as well in International)
- English fluent
- Ability to use IT tools
- Ideally, minimal 4-5 years experience in the pharmaceutical industry which include at least 3 years RA experience
- Coordination and Planning of activities
- Interactions with LOCs and stakeholders
- Ability to work in Matrix, Multi-cultural and Multi-disciplinary Environment
- Capacity to deal with complexity
- Team spirit, good relationships and leadership skills
- Flexibility (to adapt according to prioritisation)
- Very well organized
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our ‘human’ approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.