Regulatory Affairs Manager

One of our client's is urgently looking for an experienced Regulatory Affairs Manager (Regio East-Flanders):

  • Do you have at least 5 to 10 years of experience in the Pharmaceutical or Biopharmaceutical Industry?
  • Are you familiar with the planning, preparation and management of global regulatory activities (+ CRO oversight)
  • Do you speak fluently English and have a good knowledge of Dutch?

Then, you might be the specialist that we are looking for!

--> Open for Freelancers!

Job Description 

As a Regulatory Affairs Manager you will be responsible for the planning, preparation, management and follow-up of global (clinical) regulatory activities and processes, including clinical trial applications (CTAs) and INDs, scientific advice procedures, orphan designations, pediatric investigation plans and marketing authorization applications.

Responsibilities 
  • You are responsible for the preparation and follow-up of global CTA and IND submissions, including responses to Authorities and Ethics Committees

  • You follow-up the Informed Consent Form development, review and tracking in line with local requirements

  • You have an oversight on CRO regulatory activities with respect to clinical trial authorisations, including oversight on (e)TMF maintenance

  • You track and report the CTA/IND submission and approval status

  • You mainten the public study and study results registries such as clinicaltrials.gov and EudraCT.

  • You prepare and follow-up on the Scientific Advice/Protocol Assistance procedures (preparation briefing documentation, slide presentations, meeting minutes, …) at EMA, FDA or country level

  • You prepare and follow-up on the Orphan Drug Designation submissions for EMA or FDA

  • You prepare and follow-up on the Paediatric Investigation Plan submissions

  • You prepare and follow-up on the marketing authorisation applications for EMA, FDA and other Agencies

  • You update and track the regulatory documents throughout product development

  • You are responsible for the reviewing of technical documents including (clinical) study protocols, (clinical) study reports, regulatory submission documents ( InvestigatorBrochures, IMPD, IND), scientific presentations, posters, abstracts, and manuscripts with minimal guidance.

  • You follow (changes of) regulatory legislation and guidances globally, assess impact on the processes and adapted processes in line with new developments were needed

  • You enable process improvement initiatives through sharing of best practices

  • You contribute to development of processes, including preparation of standard operating procedures

  • You provide regulatory support and advice to other Clinical Development members or sub-departments and to other departments

Profile 
  • Knowledge of regulatory environment for clinical trials in EU, US and other regions (global)

  • Experience in CRO oversight

  • Scientific background allowing contribution to regulatory processes and documents on content level

  • Able to work under timeline pressure to achieve goals within set timelines while maintaining quality

  • Team Player

  • Organizational and planning skills

  • Communication skills

  • Conflict handling and problem solving

  • Detail oriented, methodical and goal driven

  • Being accountable: exercising judgment/impact of decisions/consequence of error

  • Excellent knowledge of English (spoken/written), good knowledge of Dutch is a plus

  • Computer knowledge. Proficient in Windows and MS Office (Word, Excel, Powerpoint), publishing and document management tools.

Contact Information 

Ellie Depape
 +32 15 21 11 04
ellie.depape@valesta.com

Application form : Regulatory Affairs Manager

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