Regulatory Affairs Executive

The Regulatory Affairs Executive will be part of the Innovative Medicine team at Johnson & Johnson in High Wycombe, Buckinghamshire, United Kingdom.

Responsibilities

• Develop or contribute to local regulatory strategy in line with applicable regulatory requirements.
• Responsible for specific therapeutic area activities, including agency submissions and questions, and attend cross‑functional team meetings as required.
• Perform cross‑portfolio technical and administrative activities as needed.
• Partner with the Reg Manager and cross‑functional teams to provide RA strategic and technical expertise for submissions and Health Authority (HA) interactions.
• Prepare and submit new MAA, ILAP IP, TDP, UK PIPs, and other local submissions.
• Review and approve regulatory variation documentation.
• Monitor deadlines for projects, ensuring timely completion or escalation to Regulatory Affairs Manager or Head of RA.
• Manage the content of local labelling documents released to prescribers and patients, including preparation and distribution within stipulated timelines.
• Implement Risk Management Plans and, when required, coordinate a cross‑functional team to update Risk Management Educational Material.
• Deputise for the Regulatory Affairs Manager when required.
• Complete activities to ensure compliance with all regulatory requirements.
• Develop and maintain in‑depth knowledge of regulations and legislation.
• Collect RA competitive intelligence as required.
• Act as subject‑matter expert on specific topics and author relevant SOPs, ensuring timely execution and compliance.
• Support other departments by providing documentation and information in response to requests.
• Proactively share key regulatory insights with business to shape brand strategy.
• Contact local Health Authorities to resolve general queries, ensuring positive communication.
• Participate in initiatives requested by the Head of RA, including lessons‑learnt projects and change management to improve efficiency.
• Contribute to the growth of regulatory expertise within the team by mentoring junior colleagues.

Qualifications

• Required: Licensing Compliance, Pharmaceutical Regulatory Affairs, Regulatory Affairs Compliance.
• Preferred: Analytical Reasoning, Business Writing, Coaching, Collaboration, Communication, Legal Support, Problem Solving, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Regulatory Reporting, Risk Assessments, Strategic Thinking.

Location

High Wycombe, Buckinghamshire, United Kingdom

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