Manager - Regulatory Affairs - Innovative Medicines, Europe

Tevapharm; Harlow; Hybrid; GBP 50,000 - 90,000; Full time

Job summary

Join a forward-thinking company as a Manager in Regulatory Affairs, where you will play a pivotal role in shaping the future of innovative medicines. This dynamic position involves developing regulatory strategies, obtaining approvals, and providing guidance to cross-functional teams. With a strong emphasis on collaboration and innovation, you will work on projects that impact health and well-being across Europe. Enjoy a hybrid working model, competitive benefits, and the opportunity to make a significant difference in the lives of patients worldwide. If you're ready to take your career to the next level in a supportive and inclusive environment, this is the perfect opportunity for you.

Benefits

25 days of annual leave

Hybrid working approach

Pension scheme

Car or car allowance

Life & Critical Illness Insurance

Private health insurance

Sports and Health Programme

On-site Canteen

Company bonus scheme

Qualifications

• Strong scientific background with a BSc degree in Life or Pharmaceutical Sciences.
• Substantial European regulatory affairs experience is a must.

Responsibilities

• Develop regulatory strategies for submissions to EU Competent Authorities.
• Obtain regulatory approvals for innovative medicinal products.

Skills

Regulatory Affairs

Scientific Background

Clinical Trial Applications

Leadership Skills

Interpersonal Skills

Problem-Solving Skills

Communication Skills

Education

BSc in Life Sciences

MSc in Pharmaceutical Sciences

PhD in Healthcare Sciences

Job description

Manager - Regulatory Affairs - Innovative Medicines, Europe

Date: Jan 20, 2025

Location: Harlow, United Kingdom, CM20 2FB

Job Id: 58490

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. 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.

Do you know that our Harlow office is the Centre of Excellence (CoE) for Regulatory Affairs within Teva, with teams 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. We have a hybrid approach to home working!

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

Do you have?

• 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)
• Well-being and D&I focused company

Function

Regulatory Affairs

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. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all.