Regulatory Affairs Lead
7 days ago
At Lifelancer, were on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. This mission bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds.
The company is working with the worlds leading manufacturer of innovative generic medicines, and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today, at least 200 million people around the world take one of their medicines every single day.
This role offers an exciting opportunity for a Manager or Senior Manager - Regulatory Affairs to work within the Global Regulatory Affairs Innovative Medicines (Europe) team. You will be working with key Innovative products part of Teva's Pivot to Growth strategy.
Lifelancer's Harlow office serves as the Centre of Excellence (CoE) for Regulatory Affairs within Teva, covering both European and global licensing for medicines and over-the-counter (OTC) products. The site is conveniently located half an hour commute from central London. They have a hybrid approach to home working
A day in the life of a Regulatory Affairs Lead may involve:
- Developing regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities. Depending on experience, you may also have the opportunity to do this on a Global scale in the capacity of Global Regulatory Lead.
- Obtaining regulatory approvals and other feedback or decisions from European Competent Authorities during development of innovative medicinal products.
- Supporting Clinical Trial Applications under the new Clinical Trials Regulation.
- Obtaining registrations for innovative medicinal products, in the EU and ensuring that the registrations for existing marketed products are maintained.
- Providing regulatory guidance to cross-functional teams within Teva.
To succeed in this role, you'll need:
- A strong scientific background with a BSc degree in Life or Pharmaceutical/Healthcare Sciences ideally with a MSc or PhD.
- Substantial European regulatory affairs experience (must have).
- Experience in Clinical Trial Applications in the EU (must have).
- Innovative Medicine experience in Immunology and/or Oncology and/or Gastroenterology and/or Respiratory therapeutic areas is a significant advantage, but they are open to consider any therapeutic area.
- Experience with Medical Devices and the Medical Device Regulation would also be an advantage.
- Strong leadership and interpersonal skills.
The estimated salary for this position is around £80,000 per annum, based on industry standards and location.
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