Regulatory Affairs Lead
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Job Summary
Join our UK Regulatory team and play a central role in delivering strategically important timely and high quality submissions that help bring innovative medicines and devices to patients.
Your new role
As Regulatory Affairs Lead you will manage plan and execute regulatory projects within the UK Regulatory Safety & Medical Information (RSM) team. You will provide technical and strategic support to the Associate Director of RSM and to UK Regulatory Affairs (UKRA) partner with business units to align regulatory files and labels with business and patient needs and lead complex MAA submissions and lifecycle changes (including new products line extensions and strategic projects) with the MHRA.
Day to day your tasks will include:
- 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.
Your new department
You will join the UK Regulatory Safety & Medical Information (RSM) team in Medical & Regulatory during an exciting time of growth into new therapy areas and pipeline expansion. The team works closely with Headquarters UK affiliate business units cross functional stakeholders and external partners to ensure compliance with external regulatory requirements and enable patient access to safe effective products.
Your skills & qualifications
To succeed in this role you should:
- 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 af-filiate. 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.
Working at Novo Nordisk
Every day we seek the solutions that defeat serious chronic diseases. We combine scientific curiosity warmth and determination to create lasting improvements in patient health. At Novo Nordisk you will join a collaborative team that values development integrity and cross functional teamwork and offers opportunities to make a direct impact on patients.
Deadline
28th of February (Applications are reviewed on an ongoing basis)
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk were not chasing quick fixes were creating lasting change for long-term health. For over 100 years weve been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of whats possible in healthcare. We embrace diverse perspectives seek out bold ideas and build partnerships rooted in shared purpose. Together were making healthcare more accessible treating and preventing diseases and pioneering solutions that create change spanning generations. When you join us you become part of something bigger a legacy of impact that reaches far beyond today.
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
You will be part of the Gulf Cluster sales team based in Qatar. You will report to the Country Sales Manager. The local team consists of approx 10 employees, and has highly-engaged and experienced members that are looking for a new teammember.
