Regulatory Affairs Manager

Job description

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.

Responsibilities

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.
Profile

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.
Our offer
  • 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.
Location
Gent
Contact person


Personal profile
Attachments
PDF, DOC, DOCKX (5MB)
Contact details
Tim
Janssen
Managing Partner

Do you want to learn more about Fern Valley? Are you interested in seeing how we can help your company grow? Let's get acquainted. I'll be delighted to hear your story and to share our vision. Experience the personal & open approach of Fern Valley and embark on a journey with us.

+32 487 10 61 46
tim.janssen@fern-valley.com