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- Tasks: Lead regulatory affairs processes and ensure data integrity for innovative healthcare solutions.
- Company: Join Johnson & Johnson, a leader in healthcare innovation and patient-focused solutions.
- Benefits: Inclusive work environment, competitive salary, and opportunities for professional growth.
- Why this job: Make a real impact on health by supporting groundbreaking treatments and compliance efforts.
- Qualifications: 5+ years in the pharmaceutical industry with expertise in EU regulations and compliance.
- Other info: Flexible working hours and limited travel within Europe for a dynamic work experience.
The predicted salary is between 36000 - 60000 £ 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.
This role supports the Regulatory Affairs (RA) EMEA Strategy Organisation Therapeutic Area (TA) teams with leadership for RA processes, data integrity and compliance. The role partners closely with all RA teams in EMEA, as well as with cross-regional and global stakeholders in the GRA organisation, to deliver sustainable solutions and support stakeholder needs. This role will also connect with relevant cross-functional partners in the region, e.g. Commercial Quality and Medical Safety for cross-functional alignment on process, data and compliance topics.
This role is a member of the Regulatory Affairs Process Support, Data Integrity and Compliance team within Cross-Regional Operations and Strategic Support (C-ROSS) and a key contributor to the team's success.
Key Responsibilities- Provide strategic support and tactical advice to EMEA RA Therapeutic Area (TA) teams in Europe on optimal and compliant application of RA procedures and processes, including interpretation and implementation of regulatory requirements, systems and processes.
- Coordinate input into global/regional processes and procedures impacting EMEA RA TA teams, partnering with assigned Subject Matter Experts (SMEs) as applicable.
- Ensure, coordinate, develop and/or deliver training and communication on RA processes to EMEA RA TA teams, in collaboration with assigned business process owners and SMEs.
- Identify and drive process alignment and improvement opportunities across EMEA RA TA teams.
- Act as the coordinator/owner of assigned EMEA RA TA processes.
- Ensure robust tracking and maintenance of EU RA data in J&J's and European Medicines Agency's (EMA) systems and tools.
- Provide guidance, trainings and communication on EU RA data tracking requirements in J&J's and EMA's systems and tools.
- Coordinate/provide input from an EU perspective on global RA data tracking systems, tools, requirements, projects and processes.
- Provide support and advice to EMEA RA TA teams on efficient and compliant use of RA data systems and tools.
- Ensure the appropriate level of compliance in the RA EMEA Strategy Organisation.
- Coordinate contributions from EMEA RA TA teams to audits and inspections, as needed.
- Coordinate assessment and implementation of new/revised EU regulatory requirements with RA EMEA TA impact.
- Advise EMEA RA TA teams on identification and management of non-conformances, CAPAs, quality or compliance issues.
- At least 5 years of relevant experience in pharmaceutical industry and/or Health Authorities, including proven expertise in EU Centralised Procedure, GxP and compliance activities.
- Excellent understanding of EU/EEA pharmaceutical Marketing Authorisation and Clinical Trials regulatory procedures and digital interactions with Health Authorities in EU/EEA.
- Understanding of regulatory data planning and tracking processes and systems, as well as EU data requirements (e.g. SPOR, XEVMPD).
- Knowledge of RA compliance requirements and advanced process thinking.
- Good technical skills and computer proficiency.
- Proven ability to monitor multiple actions and timelines and follow up until timely completion.
- Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level.
- Excellent cross-cultural interpersonal and influencing skills.
- Ability to communicate effectively in English, verbally and in writing.
- Flexibility and proactivity.
- Team-player.
- This position is based in Europe (Netherlands, Poland, Portugal, Spain, UK).
- Reachable during Europe office hours and outside office hours in case of emergencies.
- Flexibility for limited travel within Europe (~5%).
Manager, Regulatory Affairs Process Support, Data Integrity and Compliance EMEA in High Wycombe employer: Johnson & Johnson
Contact Detail:
Johnson & Johnson Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Manager, Regulatory Affairs Process Support, Data Integrity and Compliance EMEA in High Wycombe
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those at Johnson & Johnson. A friendly chat can open doors and give you insights that a job description just can't.
✨Tip Number 2
Prepare for interviews by researching the company culture and values. Johnson & Johnson is all about health and innovation, so think about how your experience aligns with their mission and be ready to share!
✨Tip Number 3
Practice your answers to common interview questions, but keep it natural. We want you to sound confident and genuine, not like you're reading from a script. Show them the real you!
✨Tip Number 4
Don't forget to follow up after your interview! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the role. Plus, it keeps you on their radar!
We think you need these skills to ace Manager, Regulatory Affairs Process Support, Data Integrity and Compliance EMEA in High Wycombe
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the role of Manager, Regulatory Affairs. Highlight your relevant experience in the pharmaceutical industry and any specific knowledge of EU regulatory procedures. We want to see how your background aligns with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about regulatory affairs and how you can contribute to our mission at Johnson & Johnson. Keep it concise but impactful – we love a good story!
Showcase Your Skills: Don’t forget to highlight your skills that are relevant to the role, like your understanding of compliance and data integrity. We’re looking for someone who can navigate complex processes, so make sure we see that in your application!
Apply Through Our Website: We encourage you to apply through our website for the best chance of being noticed. It’s super easy and ensures your application goes directly to the right team. Plus, we love seeing candidates who take the initiative!
How to prepare for a job interview at Johnson & Johnson
✨Know Your Regulatory Affairs Inside Out
Make sure you brush up on your knowledge of EU Centralised Procedures, GxP, and compliance activities. Familiarise yourself with the latest regulatory requirements and how they impact the pharmaceutical industry. This will not only show your expertise but also demonstrate your commitment to staying updated in a fast-paced environment.
✨Showcase Your Cross-Functional Collaboration Skills
Since this role involves working closely with various teams, be prepared to discuss your experience in cross-functional collaboration. Share specific examples of how you've successfully partnered with different stakeholders to achieve common goals, especially in a matrix organisation.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and ability to handle compliance issues. Think of scenarios where you've identified non-conformances or implemented CAPAs. Be ready to explain your thought process and the outcomes of your actions.
✨Communicate Clearly and Confidently
Effective communication is key in this role. Practice articulating your thoughts clearly, both verbally and in writing. You might be asked to explain complex regulatory concepts, so being able to simplify these for different audiences will be crucial. Remember, confidence can make a big difference!