Regulatory Affairs Executive

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 Med Tech, 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  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.

Job Function:
Regulatory Affairs Group Job Sub Function:
Regulatory Affairs Job Category:

Professional All Job Posting Locations:

High Wycombe, Buckinghamshire, United Kingdom

Job Description:

J&J Innovative Medicine – Regulatory Affairs Executive Location – Office Based – High Wycombe* – 2 days remote

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  of the role

We are seeking an assertive and confident Regulatory Affairs Executive to join our UK RA Team. The successful candidate will be responsible for helping establish and implement cost effective, results based, and professionally managed programs and innovative initiatives for the organization to advance business initiatives. Contributes to projects, programs or processes for the business area. You will also be responsible for Integrating methods based on analyses of trends in the product lifecycle for marketing applications and supplements.

Conducting sophisticated research related to labelling precedent, regulations, policies, and other topics as necessary to accurately advise on potential labelling impacts, strategies, or outcomes. As a more senior member of the team, you will be encouraged to mentor more junior colleagues in all aspects of the role and demonstrate the J&J Credo and Leadership Imperatives in day-to-day interactions with team.

Summary of responsibilities

Management of the regulatory activities in line with the existing processes to ensure compliance with regulatory requirements and an inspection ready culture. This includes:
• Develop or contribute to local regulatory strategy in line with the applicable Regulatory requirements
• Responsible for specific therapeutic area activities, including but not limited to handling the Agency submissions and questions, including cross-functional team attendance as required
• Cross portfolio technical and administrative activities as required.

Key role activities:

Portfolio and Project Management
• Partner with Reg Manager and allocated cross-functional team to provide RA strategic and technical expertise and support for submissions and HA interactions.
• Prepare and submit new MAA, ILAP IP, TDP and UK PIPs and other local submissions as assigned.
• Review and approve regulatory variation documentation
• Monitor deadlines for different projects to ensure they are met or escalated to a Regulatory Affairs manager and/or Head of RA.
• Responsible for the content of the local labelling documents released to prescribers and patients.
• Prepare and distribute local labelling documents within stipulated timelines following receipt of relevant approvals
• Implement Risk Management Plans and when required co-ordinate a cross-functional team to implement/update Risk Management Educational Material.
• Deputises for Regulatory Affairs Manager when required.

Compliance
• Complete activities to ensure compliance with all regulatory requirements
• Develops and maintain in depth knowledge of regulations/legislation.
• Supports with collection of RA competitive intelligence as…