Regulatory Affairs Manager Lead
1 month ago
We are seeking an experienced Regulatory Affairs Manager Lead to join our Global Regulatory Affairs – Innovative Medicines (Europe) team.
About the RoleThis is a key opportunity for a professional with a strong scientific background and European regulatory affairs experience to develop regulatory strategies during development, approval, and post-approval phases for submissions to EU Competent Authorities.
Responsibilities- Developing regulatory strategies for innovative medicinal products in Europe and potentially globally as a Global Regulatory Lead.
- Obtaining regulatory approvals and feedback from European Competent Authorities.
- Supporting Clinical Trial Applications under the new Clinical Trials Regulation.
- Securing registrations for innovative medicinal products in the EU and maintaining existing product registrations.
- Providing regulatory guidance to cross-functional teams within Teva.
- A BSc degree in Life or Pharmaceutical/Healthcare Sciences, ideally with a MSc or PhD.
- Substantial European regulatory affairs experience.
- Experience in Clinical Trial Applications in the EU.
- Innovative Medicine experience in Immunology, Oncology, Gastroenterology, Respiratory therapeutic areas, or other relevant fields.
- Experience with Medical Devices and the Medical Device Regulation is advantageous.
- Strong leadership and interpersonal skills.
- An attractive salary of approximately £65,000 per annum, depending on experience.
- 25 days of annual leave and a hybrid approach to home working.
- Pension scheme and private health insurance for you and your family.
- Life & Critical Illness Insurance and Sports and Health Programme.
- Recognition programs to reward employees with our company bonus scheme.
- Virtual Learning Centre opportunities.
Teva Pharmaceuticals is committed to equal opportunity in employment. We value diversity and inclusivity in our workplace and encourage applications from candidates who share these values.
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