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Regulatory Affairs Expert
2 months ago
We are recruiting for a highly experienced Regulatory Affairs expert to lead our team in Teva Pharmaceuticals’ Global Regulatory Affairs – Innovative Medicines (Europe) division. This is an exciting opportunity to work with key innovative products part of Teva’s Pivot to Growth strategy.
The successful candidate will be based at our Harlow office, which is the Centre of Excellence (CoE) for Regulatory Affairs within Teva. The site is conveniently located near central London and offers a hybrid approach to home working.
A day in the life of this role will 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 as a Global Regulatory Lead.
Key responsibilities include:
- Obtaining regulatory approvals and feedback 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 registrations for existing marketed products are maintained;
- Providing regulatory guidance to cross-functional teams within Teva;
To succeed in this role, you will require:
- 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, including Clinical Trial Applications in the EU;
- Innovative Medicine experience in therapeutic areas such as Immunology, Oncology, Gastroenterology, or Respiratory, although any therapeutic area will be considered;
- Experience with Medical Devices and the Medical Device Regulation would be advantageous;
- Strong leadership and interpersonal skills, including excellent written and verbal communication and presentation skills;
You will enjoy a competitive salary between £80,000 and £110,000 per annum, depending on experience, plus benefits including 25 days annual leave, hybrid working arrangements, pension scheme, life and critical illness insurance, private health insurance, sports and health programme, and recognition programs to reward your hard work and dedication.
