At a Glance
- Tasks: Support the development and registration of innovative pharmaceutical products across EMEA.
- Company: Join Johnson & Johnson, a leader in healthcare innovation.
- Benefits: Inclusive work environment, career growth, and impactful projects.
- Other info: Collaborative team culture with opportunities for professional development.
- Why this job: Make a difference in healthcare by working on cutting-edge oncology treatments.
- Qualifications: Bachelor's degree in life sciences and relevant experience in regulatory affairs.
The predicted salary is between 45000 - 55000 £ per year.
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.
As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.
EMEA Regulatory Affairs Solid Tumours is recruiting for a dedicated Regulatory Affairs Professional to work on the development and registration of solid tumour products in Europe, the Middle East, and Africa (EMEA). The Regulatory Affairs Professional supports the development, registration, and lifecycle management of pharmaceutical products within the EMEA region. This role focuses on regulatory tasks such as submission strategies, procedural aspects of regulatory affairs, and compliance with applicable health authority (HA) regulations, project management, and would support the EMEA regulatory leader on regulatory product strategy.
The position can be based in the United Kingdom. This role provides an opportunity to support small and large molecules, and in different oncology indications, contributing to advancements in healthcare.
The successful applicant will help develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations.
General Regulatory Responsibilities- Guide project teams on regulatory requirements and contribute to regional and local regulatory strategies.
- Support the EMEA Regulatory Leader in developing regulatory strategies for products in product development.
- Assist in submissions to health authorities, including CTAs, MAAs, and lifecycle submissions.
- Contribute to Global Regulatory and cross-functional meetings as the EMEA Regulatory Professional.
- Develop an understanding of the regional regulatory environment, therapeutic area, and competitor intelligence.
- Draft and review document content based on regulatory knowledge.
- Review clinical trial protocols to ensure alignment with regulatory requirements.
- Provide guidance on CTA submission strategies and documents such as protocols and Investigator’s Brochures (IB).
- Coordinate responses to Health Authority Questions (HAQs).
- Contribute to the development of regulatory submission documents such as briefing documents, Paediatric Investigational Plans (PIPs), and Orphan Drug Designations.
- Review response documents to ensure they thoroughly and accurately address regulatory questions.
- Provide regulatory support to the EMEA Regulatory Leader throughout the product lifecycle.
- Guide and collaborate with cross-functional teams on required documents and submission strategies for MAA preparation.
- Identify and supervise critical path activities.
- Assist with timely submission and acceptance of MAA and subsequent procedural steps.
- Ensure country-specific submission packages are made available to Local Operating Companies (LOCs) in accordance with agreed plans.
- Support lifecycle submissions and post-approval regulatory activities including Variations, Post-marketing Commitments and Safety related submissions.
- Maintain oversight of regional lifecycle submissions.
- Act as backup for contact with EMA and national Regulatory Agencies.
- Support the preparation of meetings with Regulatory Agencies.
- Collaborate with LOCs, informing regarding product and development status, addressing queries as appropriate.
- Assist in the creation and revision of processes related to regulatory submissions.
- Appropriately manage Regulatory Affairs related systems and processes according to regulatory and company standards.
- Bachelor’s degree (BS) in life sciences, medical, or paramedical fields (e.g., pharmacy, biology, veterinary science), or equivalent experience. A Master’s degree (MS), MBA, or higher qualification is considered a plus.
- Experience in pharmaceutical industry or similar and / or Regulatory Affairs 1 or more years of relevant experience, capable of working independently on key tasks while escalating higher-complexity issues.
- Experience working in cross-functional teams.
- Strong oral & written communication skills in English.
- Analytical Reasoning
- Business Behavior
- Business Writing
- Collaboration
- Communication
- Confidentiality
- Data Reporting
- Data Savvy
- Detail-Oriented
- Execution Focus
- Legal Support
- Medicines and Device Development and Regulation
- Regulatory Affairs Management
- Regulatory Compliance
- Regulatory Development
- Regulatory Environment
- Risk Assessments
Regulatory Affairs Professional EMEA in High Wycombe employer: Johnson & Johnson
Johnson & Johnson in High Wycombe is an exceptional employer, offering a dynamic work culture that fosters innovation and collaboration. Employees benefit from comprehensive growth opportunities, competitive compensation, and a commitment to compliance excellence, making it a rewarding environment for those passionate about quality systems and regulatory standards.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Professional EMEA in High Wycombe
✨Unlock Networking Opportunities
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We think you need these skills to ace Regulatory Affairs Professional EMEA in High Wycombe
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Johnson & Johnson!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Johnson & Johnson that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Johnson & Johnson!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Johnson & Johnson, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Johnson & Johnson
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Johnson & Johnson that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Johnson & Johnson’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
