Regulatory Affairs Specialist

4 semanas atrás

Amadora, Lisboa, Portugal AbbVie Tempo inteiro
Job Title: Regulatory Affairs Specialist

At AbbVie, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring the maintenance of Marketing Authorizations (CP, MRP/DCP & NP) of medicinal products and Medical Devices registrations.

Key Responsibilities:
  • Regulatory Submissions: Ensure timely and accurate submissions of regulatory documents, including label, artwork, and local prescribing information.
  • Compliance Review: Conduct thorough reviews of promotional and non-promotional materials to ensure compliance with local legislation and corporate requirements.
  • Artwork Development: Oversee the development of all package components, ensuring compliance with implementation dates.
  • Regulatory Liaison: Collaborate with national regulatory authorities to achieve optimal outcomes for patients and AbbVie's portfolio.
  • Legislative Awareness: Maintain awareness of current and new legislation/guidance, ensuring work is in compliance with all relevant statutory requirements and internal procedures.
  • Procedure Development: Write and update local procedures in compliance with local regulation and internal policies, implementing training in the affiliate as needed.
  • Regulatory Support: Provide regulatory support for the affiliate in all areas pertaining to product life-cycle management and new product development and introduction.
Requirements:
  • Education: Life sciences degree (e.g. Pharmacy)
  • Experience: Minimum of 5 years of experience in Regulatory Affairs, with expertise in medicinal products and medical devices
  • Language: Fluency in English, both in oral and written communication
  • Skills: Knowledge of information management and database administration

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

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