Regulatory Affairs Specialist (Temporary- Maternity cover)

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.

Our Team, Your Impact

We are seeking a professional for the position of Regulatory Affairs Specialist (Temporary- Maternity cover), based in Sofia, Bulgaria.

How You’ll Spend Your Day

For assigned products, ensure timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the competent authorities.

Life cycle management - ensure maintenance of assigned authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.

For assigned products ensure timely, accurate and compliant labeling updates and artwork preparation.

For assigned products and tasks, stay updated on company filings, relevant EU and local regulations and guidelines. Design and implement regulatory ad-hoc local action plans, as necessary.

For assigned products and tasks, work alongside the BD, Medical department, Business Units and Logistics, locally, regionally and globally, to support business initiatives in the region.

Your Skills and Experience

Degree or equivalent - MS degree in pharmacy or other life science, or adequate training in Regulatory Affairs

A minimum of 2-year experience in a Regulatory Affairs Department or equivalent with practical knowledge on preparing submission packages, assessing and classifying changes related to marketing authorizations

Good understanding of local and EU legislation, procedures and guidelines governing pharmaceutical products

Good organizational and planning skills

Meticulous attention to detail

Flexible enough to successfully handle conflicting time pressures and a large volume of work

A mature and disciplined approach to work is essential

Ability to take responsibility

Ability to demonstrate diplomacy and assertive skills in dealing with internal and external parties

Ability to communicate well verbally and in writing is essential

Proficiency in local and English language as well as PC use with regard to word-processing, spreadsheets, database application, and internet

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.

Already Working @Teva?

Make sure to apply through our internal career site on Twist, your one-stop shop for career development

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.