For one of our clients, a biotech company located in East-Flanders, we are looking for an experienced Regulatory Affairs Manager.
- Do you have more than 5 years of relevant experience in Clinical Research and Regulatory Affairs?
- Are you fluent in English?
- Do you have a flexible mindset and excellent interpersonal skills?
Then apply as soon as you can!
The Regulatory Affairs Manager supports the Regulatory Affairs team in preparation of Regulatory submissions including CTAs/briefing documents for US and EU, IMPD, IND.
- Prepares and/or reviews documents for completeness and accuracy; interacts with project team members to assure completeness and timing with regulatory process.
- Prepares inventory documents based on checklists prepared by regulatory personnel and /or CRO.
- Prepares and/or reviews regulatory documents for Agencies in US, EU or ROW with R&D team members.
- Conducts initial review of regulatory agency publications.
- Prepares and distributes regulatory agency contact reports and meeting minutes.
- Arranges meetings for regulatory part within project teams or regulatory agency.
- Increases knowledge of regulations and guidelines and shares new information with regulatory team.
- With oversight, conducts QC checks of materials prepared by the project team or external.
- Assists with project management, and other tasks as required by regulatory team members.
- Attends regular project team meetings.
- Develops regulatory strategy and prepares and conducts Agency meetings
- Takes care of the development of risk assessment and risk mitigation
- Filing of all matters related to nonclinical reports and clinical trials for regulatory activities from Phase 1 to 3 according to CTD.
- Supports in preparation of activities prior to BLA/MAA.
- Provides responses to regulatory agencies with support of the project team. Ensure that the document content is aligned with regulatory expectations in US, Japan and EU.
- > 5 years of relevant experience in (clinical) Research and Development within the pharmaceutical or biopharmaceutical industry.
- Applying domain knowledge: Merely possessing knowledge is not the key. Knowing how to apply domain knowledge in the field of regulatory framework development is very important.
- Excellent interpersonal skills – able to work well and build relationships across a diverse set of stakeholders and characters.
- Sound judgement and ability to analyze situations and information. Takes decisions based on facts and figures rather than on assumptions.
- Excellent project management skills.
- Flexible mindset and resistant to stress and changes in strategy.
- Able to travel based on business needs.
- Medical writing skills is an asset.
- Fluent in English (oral and written).
- University degree, Master in Life Sciences.
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