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Regulatory Affairs Manager

Há 7 dias

Lisboa, Lisboa, Portugal Buscojobs Portugal Tempo inteiro

At Buscojobs Portugal, we are seeking a highly skilled Regulatory Affairs Specialist to oversee a range of regulatory activities for our consumer healthcare products.

The Role
  • We are looking for a Regulatory Affairs Associate who will be responsible for compilation and submission of applications (post approval and new submissions), resolution of Health Authority questions in cooperation with other functions, post-approval commitments and submission of variations/renewal applications where requested.
  • The ideal candidate will have a strong understanding of the regulatory environment and supporting data requirements.

Key Responsibilities:

  1. Develops and maintains a thorough understanding of the regulatory environment and supporting data requirements.
  2. Prioritizes, plans and monitors allocated projects against defined timelines.
  3. Monitors the progress of the regulatory authority review process through appropriate communication with the Health Authority.

What We're Looking For

  • Knowledge of consumer healthcare environment and product development.
  • Understanding of processes and departments within a healthcare company.
  • Effective time and organization management.
  • Proficiency in English.