Regulatory Affairs Specialist

We Are Teva

We’re Teva, a leading innovative biopharmaceutical company, enabled by a world-class generics business. Whether it’s innovating in the fields of neuroscience and immunology or delivering high-quality medicine worldwide, we’re dedicated to addressing patients’ needs now and in the future. Here, you will be part of a high-performing, inclusive culture that values fresh thinking and collaboration. You'll have the room to grow, the flexibility to balance life with work, and the opportunity to better health worldwide, together.

Role Summary

 

We are seeking a Regulatory Affairs Specialist to manage and support regulatory activities for pharmaceutical products on the Romanian market, ensuring compliance with national (ANMDMR) and EU regulations.

Key Responsibilities

 

• Prepare and manage regulatory submissions (national, variations, renewals)
• Maintain product licenses and regulatory documentation for medicinal products
• Monitor regulatory changes and assess impact on registered products
• Support launches, lifecycle management, and compliance activities
• Translations / coordination of translations with an agreed supplier for specific documents from Romanian into English and from English into Romanian
• Follow up on the submitted files, requesting additional documents
• Update databases with relevant information according to company procedures

Requirements

 

• Degree in Pharmacy
• 2-3 years of Regulatory Affairs experience in pharmaceuticals
• Solid knowledge of Romanian and EU pharmaceutical legislation
• Fluency in Romanian and English 
• Good communication skills, proactive
• Previous experience in Quality related activities is a plus

How We’ll Take Care of You

At Teva, better health starts from within, and that includes you. From day one, you’ll be supported with benefits designed to help you thrive in and out of work. This includes generous annual leave, reward plans, flexible working schedules (dependent on role), access to tailored health support, and meaningful ways to give back to the community.  When it comes to your career, you’ll be encouraged to explore, evolve, and shape your path. Twist, our one-stop shop for career development platform, gives you access to a wide range of possibilities, from learning programs and short-term projects to opportunities for internal growth. Here, you’ll be part of a culture that empowers you to reach your goals and prioritize your wellbeing every step of the way. 

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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.