Regulatory Affairs ociate

Who We Are

Together were on a mission to make good health more affordable and accessible to help millions around the world enjoy healthier lives. Its 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 worlds leading manufacturer of generic medicines and the proud producer of many of the products on the World Health Organizations Essential Medicines List. Today at least 200 million people around the world take one of our medicines every single day. An amazing number but were always looking for new ways to continue making a difference and new people to make a difference with.

How Youll Spend Your Day

Assessment of change controls for registration impact and implementation of all necessary dossier changes in; Europe and International Market

Responsible for compilation of the variations for the products in the product portfolio in collaboration with other stakeholders

Compiling variation packages

Experienced in managing regulatory database and Trackwise.

Qualification

Your experience and qualifications

Academic degree and thinking level with a chemical/pharmaceutical background.

Experience

• 25 years of experience in CMC Regulatory Affairs; Mainly in Europe and International Market
• Knowledge on registration procedures and pharmaceutical regulations
• Interest and capability to work with different software including Document Management System
• Accurate able to prioritize and work according to agreed timelines.
• Working independently with a moderate level of guidance and direction.
• Solve complex problems using existing solutions and support.
• Identify implement process improvements.
• Team player

Reports To

Sr Manager CMC Regulatory Affairs

Tevas Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Tevas 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.

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Remote Work :

No