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Head of Regulatory Affairs UK and Ireland
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
Your role: You lead a local team of regulatory professionals to meet current and future Regulatory Affairs (RA) objectives in alignment with the UK&IL commercial objectives. You formulate short and long term vision for local RA function to ensure functional and internal cross-functions alignment. You support Head of RA Europe to define country specific submission strategies and to implement them locally as per plan. You act as local RA expert to provide strategic input on the application of local regulations, review processes and submission requirements. You take ownership for the content of local submission and maintain full awareness of all RA activities on local portfolio, ensuring project deadlines and performance standards are met. You ensure review and release of promotional material according to local regulations and corporate procedures. You act as Merck representative with local Health Authorities for all regulatory matters and with local industry associations to aim shaping local environment based on global guidance.
Who you are:
- A regulatory affair professional with leadership experience in the pharmaceutical industry.
- Degree in a quality or relevant scientific discipline.
- Good working knowledge of pharmaceutical regulations within UK, Ireland and across EU.
- Motivated, meticulous individual with excellent organisational, communications and technical writing skills.
- Proven track record of organising workload and activities to meet required deadlines.
- Excellent stakeholder management and engagement skills, both internal and external.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
We are committed to promoting a diverse and inclusive workforce. Applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.