Regulatory Affairs Specialist

4 semanas atrás


Lisboa, Lisboa, Portugal Abbvie Tempo inteiro
About the Role

As a Regulatory Affairs Specialist at AbbVie, you will play a critical role in ensuring the maintenance of Marketing Authorizations for medicinal products and Medical Devices registrations. This includes variations and other regulatory submissions, including label, artwork, and local prescribing information.

Key Responsibilities
  • Maintain awareness of current and new legislation/guidance to ensure compliance with all relevant statutory requirements and internal procedures.
  • Review promotional and non-promotional materials to ensure compliance with local legislation and corporate requirements.
  • Liaise with national regulatory authorities to obtain optimal outcomes for patients and AbbVie's portfolio.
About the Team

You will be part of a dynamic team that is passionate about delivering innovative medicines and solutions. Our team strives to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

What We Offer
  • A competitive salary of $90,000 - $110,000 per year, depending on experience.
  • The opportunity to work with a global leader in the pharmaceutical industry.
  • A comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
Requirements

To succeed in this role, you will need:

  • A Life sciences Degree (e.g. Pharmacy).
  • A minimum of 5 years of experience in Regulatory Affairs in the responsibilities mentioned above.
  • Fluency in English, both in oral and written communication.
  • Knowledge of information management and database administration.

We are an equal opportunity employer and are committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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