In the context of our growing activities, we are looking for a Regulatory Affairs Specialist to join our teams in Portugal.

Group 10

  • Provide guidance and support to continue managing submissions and any other requests from one of our mains clients regarding Portugal.
  • Develop local Portugal Regulatory Affairs presence, taking responsibility for new regulatory activities related to Portugal
  • Contribute to the regulatory activities performed. Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Compile regulatory dossiers in accordance with national requirements.
  • Systems Management and Administration
  • Document and track regulatory submissions and regulatory authority approval.
  • Provide regulatory support to clients and associate companies
  • Liaise with sponsor head-office and affiliate departments on regulatory issues.
  • Provide review of packaging texts.
  • Provide format review of Summary of Product Characteristics, Patient Information Leaflets, and labelling (e.g., QRD compliance check).
  • Contribute to data entry in PLG tools enabling measurements of KPI, metrics for regulatory services

Group 11
Education & Experience

  • Bachelor’s degree or more in a Life Sciences related field. Pharmacy degree would be a plus.
  • At least 5 years of experience in Regulatory Affairs in the Pharmaceutical Industry or via a Service Provider
  • Previous experience in a consulting company would be a plus

Group 13

Hard/Technical skills:

  • Experience in regulatory lifecycle maintenance activities for drug products (Renewals, PI updates, technical variations)
  • Knowledge of PT regulation for pharmaceuticals (NCE, Biologicals and Biotech), Medical Devices, Combination products and Cosmetics
  • Strong computer skills, including MS Office applications, data and document management systems
  • Experience in project management
  • Experience in the new registrations of drug products is preferable.
  • Fluency in Portuguese and English

Soft skills:

  • Excellent organizational and interpersonal skills
  • Very good coordination skills
  • Autonomous
  • Excellent communication skills
  • Ability to work well within a team and autonomously
  • Ability to prioritize different workloads/multi-task
  • Process orientated with good attention to detail
  • Solution-driven

Regulatory Affairs Specialist - 701