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Senior Regulatory Affairs Professional, High Wycombe
Client:
Johnson and Johnson
Location:
High Wycombe, United Kingdom
Job Category:
Other
EU work permit required:
Yes
Job Reference:
d454ffe9e149
Job Views:
7
Posted:
02.04.2025
Expiry Date:
17.05.2025
Job Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com.
Job Function:
Regulatory Affairs Group
Job Sub Function:
Regulatory Affairs
Job Category:
Professional
All Job Posting Locations:
High Wycombe, Buckinghamshire, United Kingdom
About Innovative Medicine:
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. Learn more at https://www.jnj.com/innovative-medicine.
Job Description:
Janssen EMEA Neuroscience, Cardiovascular, Metabolic and Retina (NCMR) team is recruiting for a dedicated Experienced or Senior Regulatory Affairs Professional to work on the development and registration of NCMR products in Europe, the Middle East, and Africa (EMEA). The position can be based in Belgium, the United Kingdom or the Netherlands - other locations can be discussed on a case-by-case basis. The job provides an opportunity to support small and large molecules, as well as advanced therapies, in different NCMR disease areas, contributing to healthcare one patient at a time.
Responsibilities:
1. Input in clinical development and post-approval: Support the EMEA Regulatory Liaison in developing the regulatory strategy for products in development and assist in submissions to health authorities from early development, CTAs to MAAs and life-cycle management.
2. Liaison with Regulatory Agencies and Local Operating Companies: Act as backup for contact with EMA and national Regulatory Agencies. Support the preparation of meetings with Regulatory Agencies.
3. Input in document and process development: Assist in the creation and revision of processes related to regulatory submissions.
4. Clinical Trial Applications: Review protocols and ensure alignment with regulatory requirements.
5. Marketing Authorization Applications: Provide regulatory support throughout the life-cycle of a product.
Job Requirements:
Education and experience: Master's degree - medical or paramedical (pharmacy, biology, veterinary, etc.), or equivalent by experience. Proven experience of 2+ years in regulatory affairs or other relevant functions (4+ for Senior).
Skills: Project management, strong oral & written communication skills, organization, prioritizing, and multi-tasking skills.
Knowledge: Knowledge of the pharmaceutical regulatory environment, guidelines, and practice in EMEA, particularly the EU.
Please note: This role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. Check our Blog for more information.
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Created on 02/04/2025 by TN United Kingdom
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