Regulatory Affairs Professional with EU Market Expertise

Há 1 mês


Lisboa, Lisboa, Portugal Adecco Tempo inteiro

About the Role

We are currently recruiting for a Regulatory Affairs Specialist to join our team in Sintra, Portugal. This is an exciting opportunity to work with a leading pharmaceutical company and contribute to the launch of new products.

Key Responsibilities:

  • Handling post-approval activities related to Abbreviated New Drug Applications (ANDAs), Marketing Authorizations Applications (MAA), and variations/supplements to current ANDA/MA/ANDS.
  • Evaluating Change Controls, preparing product information variations/labelling supplements, and providing information for Annual Product Review (APRs).
  • Supporting the site on the launch of new products by performing all regulatory activities required.
  • Preparing, reviewing, and implementing labelling.

Requirements:

  • Masters degree in Pharmaceutical Sciences or equivalent experience.
  • Experience in EU Market Regulatory Affairs is preferred.
  • 4-6 years of professional experience in the pharmaceutical industry.
  • Strong analytical and negotiation skills, as well as ability to work under pressure and meet deadlines.

What We Offer:

  • A direct contract with our client company.
  • A competitive salary of around €60,000 per year, commensurate with experience.
  • Life insurance and health insurance benefits.
  • An annual performance bonus based on individual performance.

About Us:

Adecco is a leading staffing agency providing temporary and permanent workforce solutions across various industries. We value innovation, customer satisfaction, and employee development.



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