Regulatory Affairs Manager
For the expansion of our Regulatory Affairs team, our customer is looking for a Regulatory Affairs Manager to support the teams in preparation of Regulatory submissions including CTAs/briefing documents for US and EU, IMPD, IND.
The position will have the following key responsibilities:
- 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.
More than 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.
- An attractive salary in line with your experience and skills.
- Fringe benefits including a medical insurance, pension plan and a care plan.
- A supporting environment.
- Respect for the life-work balance.
- Career planning.
- A focus on professional and personal growth through training and coaching.
- Room for personal engagement to help shape our company's future.