Regulatory Affairs / Alignment Support Manager - Belgium
- Analyse the regulatory requirements in International region for the submissions included in Product Alignment,
- Develop a regulatory strategy that optimizes supply continuity of products
- Identify potential risks/blockers and develop an action plan to mitigate those risks/blockers
- Develop Ways of Working to optimize the preparation of the submission in International region and associated lead-times.
- Develop an engagement plan with the Hubs, LOCs and regulatory authorities in order to facilitate the submission and approval.
- Report progress to the team
- University degree preferably in life sciences. Basic regulatory knowledge is a pre-requisite.
- Experience in registration of for biological products in International region would be beneficial.
- Self-motivated with the ability to work independently.
- Ability to work in matrix environment and with remote teams.
- Analytical thinking; Strategic thinking. Ability to manage complexity and interrelations.
- A flexible and enthusiastic approach to work will be needed to function effectively within this complex project.
- Good presentation/communication skills, oral and written, fluent in English.
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.