Regulatory Affairs Executive in High Wycombe

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.

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 to advance business initiatives, and contribute to projects, programs or processes for the business area. You will also integrate methods based on analyses of trends in the product lifecycle for marketing applications and supplements, conduct sophisticated research related to labelling precedent, regulations, policies, and other topics to advise on potential labelling impacts, strategies or outcomes. As a senior member of the team, you will mentor junior colleagues and demonstrate the J&J Credo and Leadership Imperatives in day‑to‑day interactions.

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.
• Develop or contribute to local regulatory strategy in line with applicable regulatory requirements.
• Responsible for specific therapeutic area activities, including handling agency submissions and questions, and attending cross‑functional team meetings as required.
• Cross‑portfolio technical and administrative activities as required.

Key Role Activities

• Partner with Reg Manager and allocated cross‑functional team to provide RA strategic and technical expertise for submissions and HA interactions.
• Prepare and submit new MAA, ILAP IP, TDP, 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 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, coordinate a cross‑functional team to update Risk Management Educational Material.
• Deputise for Regulatory Affairs Manager when required.

Compliance

• Complete activities to ensure compliance with all regulatory requirements.
• Develop and maintain in‑depth knowledge of regulations/legislation.
• Support collection of RA competitive intelligence as required.
• Subject‑matter expert on given topic and author of relevant SOPs, assuring timely execution and compliance.

Internal/External Contacts

• Support other departments by providing documentation and information in response to requests.
• Proactively share key regulatory insights with business to help shape brand strategy.
• Contact local Health Authorities to resolve general queries when they cannot be addressed internally, ensuring positive communication.

Miscellaneous

• Undertake, support and contribute to initiatives as requested by Head of RA.
• Contribute to initiatives around lessons learned and change management to ensure efficiency gains.
• Actively contribute to growing the regulatory expertise of the team by mentoring junior regulatory colleagues.

By joining Johnson & Johnson you will find boundless opportunities to shape your path and amplify your impact inside and outside our walls. With our commitment to be the world’s healthiest workforce, you can strengthen your body as well as your mind. You can touch over a billion lives worldwide every day by applying your talent to our collective purpose.

We aim to create an environment where you can bring your whole self to work. We offer competitive compensation and benefits, including private healthcare, retail vouchers, discounted and subsidised gym memberships, and support for community projects through our global Corporate Social Responsibility programme.