Regulatory Affairs Officer

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.

The opportunity

We are looking for a Regulatory Affairs Associate/Officer to join us in Teva Porto-Salvo office. We have a hybrid approach to home-working!

You mission will be to coordinate and prepare applications for registration, variations, revalidations and pricing to obtain approvals from the Portuguese and European regulatory authorities, ensuring that the appropriate processes for the registration, launch and maintenance of our products are complied with in a timely manner and that safety and quality control standards are met.

How you’ll spend your day

• New Registration Applications (National/MRP/DCP/CP)
  • Preparation of registration file and requirements within the established deadlines
  • Follow-up of registration, deficiency letters, allegations and responses to authorities, agree final texts with INFARMED to obtain marketing authorization.
  • Artworks: elaboration, review and approval of artworks for new releases 
  • Management of registration status information 
  • Preparation of price requests, price alterations and reimbursement 

• Variation Requests (National/DCP/MRP/CP)
  • Evaluation of documentation and request for additional documentation necessary for timely submission.
  • Preparation and presentation (NEES / e-CTD)
  • Coordination of responses to deficiency letters in order to ensure timely replies
  • Follow-up until approval, with calendar monitoring
  • Communications to Regulatory Centres and internally for implementation upon authorisation (Change Control)
  • Artworks: elaboration/modification, review and approval of artworks for implementation of authorised changes 
  • Five-yearly revalidations

• Other Responsibilities
  • Extraordinary requests from INFARMED (updating of texts according to CCSIs, requests for temporary suspension, cancellations)
  • Reviewing, updating and monitoring current legislation to ensure compliance
  • Use of the company's internal databases for work management (Global Insight, Wisdom, Sage, ADAM)
  • Knowledge and application of departmental and company policies and procedures which are applicable
  • Customer queries management
  • Internal queries support related with the portfolio in charge

• Archives
  • Maintenance of the electronic archive of medicinal products and the documentation generated from Registrations.

Your experience and qualifications

• At least 1 full year experience in similar positions
• Academic level degree in Pharmaceutical Sciences.
• Master's degree related to regulatory activities would be an advantage.
• High level of English (first interview will be done in English)
• Demonstrable proficiency in Microsoft Office including Excel 
• Results-oriented
• Excellence in execution: agility, celerity and safety 
• Prioritisation of tasks. Pragmatism and perseverance
• Resolving capacity.

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. 

Reports To

Senior Manager Regulatory Affairs

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.