Manager Regulatory Affairs CMC - Innovative Medicines
Date:
Nov 24, 2025
Location:
Zagreb, Croatia, 10000
Company:
Teva Pharmaceuticals
Job Id:
65112
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
- Develop, coordinate, and support the CMC aspects of regulatory submissions to global Health Authorities for innovative medicines.
- Lead and implement regional and/or global CMC strategy and submission activities, including:
- Planning, writing, reviewing, coordinating, and submitting CMC sections of regulatory filings for assigned projects and products.
- Arrange, coordinate, and lead the team in planning, preparation, and execution of meetings or teleconferences with Health Authorities (e.g., FDA, EMA) as lead facilitator.
- Guide subject matter experts (SMEs), Operations, and/or QA functions to implement activities aligned with global strategies and regulatory agency requests and guidance.
- Anticipate and understand the needs of internal and external customers.
- Identify current key issues and anticipate future ones, taking them into consideration when planning and managing projects.
- Challenge the status quo to achieve continuous improvement.
- Manage change control: coordinate and assess regional/global change records.
Your experience and qualifications
Education:
- Required: Bachelor’s degree in a scientific field (Pharmacy, Chemistry, Biochemistry, Biotechnology, or equivalent)
- Preferred: Master’s degree, PhD, or PharmD
Experience:
- Required: Minimum 4 years of pharmaceutical industry experience, preferably in regulatory affairs
- Preferred: Minimum 6 years of regulatory affairs experience with proven success in filing and defending major submissions
Technical competencies:
- Strong background in pharmaceutical development with focus on CMC (drug substance and drug product)
- Experience with ICH Guidelines Q8, Q9, Q10 and ObD principles
- Familiarity with CTD filings (Modules 2 and 3), content, and regional CMC requirements
- Working knowledge of relevant drug and biologic laws, regulations, and guidelines
- Knowledge of pharmaceutical drug development process
- Proficient in project management
Soft skills and behavioral competencies:
- Ability to manage multiple projects and competing timelines
- Strong strategic and scientific thinking
- Good interpersonal, communication, organizational, and negotiation skills
- Ability to influence through logical, reasoned communication and respond constructively to others’ needs
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
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.
