Regulatory Affairs Lead
Novo Nordisk
full-time
Posted on:
Location Type: Office
Location: Gatwick • United Kingdom
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Job Level
About the role
- Lead regulatory projects end to end: planning resources and budgets, developing and leading the regulatory strategy, performing risk analysis and delivering implementation plans.
- Act as UK point of contact for allocated projects, including official meetings with health authorities (e.g., Scientific Advice), trade and industry association meetings, and represent UKRA in Global Regulatory Portfolio Matrix Teams, where required.
- Compile, prepare and ensure submission and approval of national MAAs and other regulatory applications in collaboration with HQ, publishing, labelling, devices and cross functional stakeholders.
- Maintain regulatory intelligence: monitor changes in UK (MHRA) and EU legislation, evaluate relevance and interpret impact for UK operations and regulatory strategy.
- Provide accurate internal regulatory advice and training to business units on regulatory requirements, and any other adhoc projects requiring high level regulatory expertise.
- Support regulatory audit and inspection readiness, paediatric obligations (PIP activities), recall procedures and other GxP related activities as required.
Requirements
- Be a science graduate (or equivalent) with relevant pharmaceutical industry experience in a regulatory environment (minimum 8-10 years relevant Regulatory experience)
- Demonstrate extensive knowledge of regulatory legislation and processes (UK and EU) and the ability to interpret new legislation and assess business impact.
- Have proven experience managing business critical regulatory projects and compiling regulatory submissions for new and innovative medicinal products.
- Experience working with medical devices is advantageous.
- Be able to lead with valuable stakeholder management with influencing skills; able to provide clear regulatory advice and work collaboratively across HQ, Region and the UK affiliate.
- Experience working across a senior management matrix is beneficial.
- Be proficient with Microsoft systems, comfortable prioritising tasks to meet deadlines, and able to work both autonomously and as part of a team.
- Be fluent in written and spoken English with excellent communication and presentation skills.
- Have the ability to make sound decisions on complex regulatory issues and proven problem solving skills.
Benefits
- Health insurance
- Professional development opportunities
- Flexible working hours
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory strategyrisk analysisregulatory submissionsregulatory intelligenceGxPPIP activitiesregulatory auditregulatory processesregulatory legislationmedical devices
Soft Skills
stakeholder managementinfluencing skillscommunication skillspresentation skillsproblem solvingdecision makingcollaborationautonomyprioritizationteamwork