- Home
- Vacatures
- Vacatures Leiden
- Vacaturedetails
Vacature doormailen
Regulatory Affairs Professional Leiden • Randstad
- Notitie toevoegen
- Vacature verbergen
- Vacature rapporteren
Gevraagd
-
37 - 40 uur
-
Engels (taal)
Aanbod
-
Vast contract
-
4.500 p/m (bruto)
-
Reiskostenvergoeding
Vacature in het kort
Over het bedrijf
Volledige vacaturetekst
FunctieomschrijvingAt 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!
- Salary starting at €4500
- Renowned international & diverse company
- Development offered by a dedicated L&D department
- OV fully reimbursed, easy access from highway
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
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
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 applicationIs 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.SollicitatieprocedureJe 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!
Vanaf nu ontvang je automatisch de best passende vacatures automatisch in je mailbox.
Jouw inschrijving
Emailadres:
Functie:
Plaats:
Frequentie:
Wijzig je inschrijving
Ontvang als eerste nieuwe vacatures in Leiden
Vind werknemers in Leiden op Werkzoeken.nl