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. 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 generic medicines, and the proud producer of many of the products on the World Health Organization's Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we're always looking for new ways to continue making a difference, and new people to make a difference with.
How You'll Spend Your Day
- Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
- Responsibility for MA compliance with both legislation and business needs.
- Prioritise, plan and monitor submission for allocated procedures while documenting and informing involved parties of progress.
- To give regulatory support to project teams, stake holders and European Units for defined product responsibilities.
- Support the development and implementation of regulatory strategies for defined projects.
- Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
- Maintain and develop awareness of current/pending regulatory legislation and guidelines.
- Support the defined processes within the department and provide input where improvements can be made.
- Awareness of current/pending regulatory legislation and guidelines
Your Experience And Qualifications
Required Degree: Master in Pharmacy or Master in science/life sciences
Experience
- Relevant years of experience required for the role: 4 to 6 years in Regulatory affairs with EU post approval
- Overall Pharma industry experience: 4 to 6 years
- Desirable to have EU member state experience and knowledge of European regulatory procedures.
Knowledge
- EU member state experience and knowledge of European regulatory procedures (Mutual Re
- cognition, Decentralised and Centralised Procedures).
- CMC
- Change control process
- Understanding of processes and departments within a pharmaceutical company
Skills
- Excellent oral and written communication (English)
- Ability to work under pressure and to tight time deadlines
- Effective time and organisation management
- Negotiation
- Initiative
- Analytical (Data and Documentation)
- Computer literacy
- Presentation skills
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. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
