Regulatory Affairs Professional

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!

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.

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

Waldo Kriel

Recruiter

Do you have any questions? Please feel free to contact me. You can reach me by phone or email. We look forward to receiving your application!

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