Voisin Consulting Life Sciences job icon
Job

IWAC | Senior Regulatory Science Specialist | Denmark

Denmark

 

IWA Consulting is part of the VCLS a global life science consulting business and this role will see you work locally with IWA Consulting and benefit from the global career development opportunities of VCLS.

You will assist clients with a variety of regulatory tasks including the following:

Regulatory Strategy preparation:

  • Prepare regulatory strategies and provide input to regulatory strategies for pharma projects.
  • Identify and provide relevant regulatory guidance to clients, incl. defining the regulatory path.

Project Management and Procedure Management:

  • Project Management for regulatory activities on pharmaceutical products,
    incl. management of US and EU regulatory procedures (incl. MAA, NDA, IND, CTA, ODD, PIP, variations, renewals, and other post-approval activities).
  • Planning, coordinating and participating in meetings with authorities.

Preparation and submission of all types of regulatory documents and dossiers:

  • Preparation and/or review of documentation for regulatory submissions,
    incl. MAA, NDA, IND, CTA, ODD, PIP, variations, and renewals.
  • Preparing for, and review of, eCTD submissions.

 

Preparation and updating of Product Information text:

  •  Preparation and updating SmPC, PIL and Labelling.

Medical/technical writing:

  • Medical/technical writing for pharma products.

Teaching/speaking at courses and conferences:

  • Teaching/speaking at courses, conferences or similar on various subjects
    according to existing and acquired key competencies.

Required

  • MSc Degree in Life Sciences or equivalent
  • Regulatory Science experience
  • Excellent communication
  • An ambitious to build a career in Life Science Consulting