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Manager - Regulatory Affairs - Innovative Medicines, Europe, Harlow
Job Location: Harlow, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 96d09b871b74
Job Views: 6
Posted: 13.02.2025
Expiry Date: 30.03.2025
Job Description:
Job Title: Manager - Regulatory Affairs - Innovative Medicines, Europe
Job Location Type: Hybrid
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
Who We Are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. Working here means working with the world’s leading manufacturer of innovative & generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List.
The opportunity
We are recruiting 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.
A day in the life of a Manager/Senior Manager Regulatory Affairs...
* You will develop regulatory strategies during development, approval and post approval phases for submissions to EU Competent Authorities. Depending on your experience you may also have the opportunity to do this on a Global scale in the capacity of Global Regulatory Lead.
* You will obtain regulatory approvals and other feedback or decisions from European Competent Authorities during development of innovative medicinal products.
* You will support Clinical Trial Applications under the new Clinical Trials Regulation.
* You will obtain registrations for innovative medicinal products in the EU and ensure that the registrations for existing marketed products are maintained.
* You will provide regulatory guidance to cross-functional teams within Teva.
Your Experience And Qualifications
* 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 we 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.
Are you?
* An excellent written and verbal communicator and confident presenting/communicating with local and global groups.
* Able to work under pressure to meet tight deadlines.
* A strategic thinker with strong problem-solving skills.
Enjoy a more rewarding choice
* Enjoying time with your families (25 days of annual leave, Hybrid approach to home working, Pension scheme, car or car allowance).
* Looking after your health (Life & Critical Illness Insurance, Private health insurance for you and your family, Sports and Health Programme – including health days and nutritional counselling, On-site Canteen).
* Recognizing your value (Recognition programs to reward our employees with our company bonus scheme).
* Boosting your potential (Virtual Learning Centre).
* Well-being and D&I focused company.
Function: Regulatory Affairs
Sub Function: Medical Regulatory Affairs
Reports To: Associate Director, EU Regulatory Affairs Innovative Medicines
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. We are committed to a diverse and inclusive workplace for all.
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