+30 km
Uren
Opleiding
Dienstverband
Ervaring
Salaris
Datum
Bedrijfstype
Zoek vacatures
Soortgelijke vacatures omgeving Leiden.
Laad meer vacatures

Regulatory Affairs Professional Leiden Randstad

Solliciteer nu
Solliciteer als één van de eersten
Opslaan
Solliciteer nu
Opslaan
Delen

Gevraagd

  • 37 - 40 uur
  • Engels (taal)

Aanbod

  • Vast contract
  • 4.500 p/m (bruto)
  • Reiskostenvergoeding
 

Vacature in het kort

Leiden
Join a renowned international company dedicated to transforming lives through science. As an Experienced Regulatory Affairs Professional, you'll play a vital role in bringing groundbreaking oncology treatments to patients across Europe, the Middle East, and Africa. Enjoy development opportunities from a dedicated L&D department and fully reimbursed travel expenses. Collaborate in a fast-paced, cross-functional environment, contributing to life-changing cancer treatments. Apply now to make a difference! Continue reading to see how this role can broaden your professional horizons.
 

Over het bedrijf

Randstad
Uitzendbureau
Bedrijfsprofiel
 

Volledige vacaturetekst

Functieomschrijving

At Janssen EMEA Oncology, part of Johnson & Johnson Innovative Medicine, we are united by a mission to transform lives through science. We’re looking for an Experienced Regulatory Affairs Professional to help bring breakthrough oncology treatments to patients across Europe, the Middle East, and Africa (EMEA).
If you are passionate about driving regulatory strategy in a fast-evolving therapeutic area, and want to contribute to life-changing innovation, then this is your chance, apply now!

what we offer
  • Salary starting at €4500
  • Renowned international & diverse company
  • Development offered by a dedicated L&D department
  • OV fully reimbursed, easy access from highway
who are you

You are a motivated regulatory professional who thrives in a cross-functional, fast-paced environment. You’re ready to contribute to innovative cancer treatments that impact lives across the EMEA region.

  • Master’s degree in a medical, pharmaceutical, or life sciences field (e.g., Pharmacy, Biology, Veterinary Science), or equivalent experience
  • Minimum of 2 years of regulatory affairs or closely related experience (4+ years for Senior level)
  • Experience working in cross-functional teams on regulatory submissions and strategies
  • Strong project management and organizational skills
  • Excellent oral and written communication
  • Proven ability to prioritize and manage multiple projects
  • Solid knowledge of EMEA/EU regulatory guidelines and practices
what will you do

As an Experienced or Senior Regulatory Affairs Professional, you’ll support the development and registration of Hematology or Solid Tumor Oncology products across Europe, the Middle East, and Africa (EMEA). Your key responsibilities will include the following;

  • Support the development and execution of EMEA regulatory strategies from clinical trial applications (CTA) through to marketing authorization applications (MAA) and variations
  • Contribute as the EMEA Regulatory representative in global project meetings
  • Provide regulatory guidance to cross-functional project teams
  • Interact with regulatory agencies and local operating companies (LOCs), including preparation of meeting documentation
  • Review and draft content for regulatory submissions, including briefing packages, response documents, and designations (e.g., PIP, ODD)
  • Ensure timely and complete CTA and MAA submissions in collaboration with internal teams and LOCs
  • Track regulatory milestones, questions, and approvals across the product lifecycle
where will you work

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life — while championing patients every step of the way.

job application

Is this vacancy a match for you? Get in touch with us today to plan in an interview!

Uiteraard staat deze vacature open voor iedereen die zich hierin herkent.Sollicitatieprocedure
Je maakt een 'mijn Randstad' account aan om te kunnen reageren op onze vacatures. Dit doe je automatisch wanneer je voor het eerst een sollicitatie afrondt bij Randstad, heel eenvoudig dus. Via je 'mijn Randstad' account beheer je gemakkelijk je gegevens en gaan je volgende sollicitaties nog sneller!
Vacature opslaan
 Vacature delen
Sluit
Je notitie is succesvol opgeslagen
Voeg een notitie toe aan deze vacature
Opslaan
Sluit
Bedankt, je melding is verstuurd
Rapporteer deze vacature
Leg kort uit waarom je deze vacature rapporteert:
Versturen
Terug naar vacatures
Sluit
Kies 1 of meer
Sluit
Vacature opgeslagen
Klik op het hartje bovenaan de pagina om je opgeslagen vacatures te zien.
Terug naar vacatures
Sluit
Vul een in