Regulatory Affairs Specialist

4 semanas atrás


Lisboa, Lisboa, Portugal Phiture Tempo inteiro
Job Description

At Phiture, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will be responsible for ensuring the maintenance of Marketing Authorisations for medicinal products and Medical Devices registrations, through variations and other regulatory submissions.

Main Responsibilities:

  • Review and ensure compliance with local legislation and corporate requirements for promotional and non-promotional materials.
  • Develop and implement artwork for package components in accordance with implementation dates.
  • Liaise with national regulatory authorities to obtain optimal outcomes for patients and our portfolio.
  • Maintain awareness of current and new legislation/guidance and ensure compliance with all relevant statutory requirements.
  • Write and update local procedures in compliance with local regulation and internal policies and procedures.

Qualifications:

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

About Us:

Phiture 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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