Regulatory Affairs Officer

Our client is a regulatory and scientific consultancy company focused on the pharmaceutical industry, with a team specialized in the area and extensive experience in the medicine and health products sector:

Regulatory Affairs Officer - ALMADA

The holder of this position will be responsible for providing guidance on regulatory requirements as well as assisting in regulatory related projects and tasks ensuring compliance with all national and international regulations, ISO standards, and other regulatory agencies.

Profile required:

• Bachelor's or Integrated Master's degree in Pharmaceutical Sciences or Law or similar (preferred)
• 2-3 years' experience in regulatory affairs/Quality Assurance/Legal Affairs
• Knowledge and experience in GDPR-related matters
• Proficiency in spoken and written English
• Immediate availability (preferred)

The tasks to be carried out are in the following areas:

• Marketing authorizations
• Registration files
• AIMS maintenance activities
• ECTD/NEES
• Promotional and non-promotional materials & promotional activities
• Regulatory and scientific advice
• Pharmacovigilance
• Leaflet readability tests
• Quality - quality management systems
• Prices and reimbursements
• Certification of medicines
• Quality/technical management (good distribution practices - GDP)
• Compliance

Valued personal skills:

• Teamwork
• Resilience
• Responsibility and autonomy
• Attention to detail and meeting deadlines
• Excellent verbal and written communication skills

If you are looking for a new challenge and identify with the profile and requirements, please send your CV and motivation letter in English to @ , quoting Ref.

106/RAO/2024 in the subject line.

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