In the context of our growing activities with some of our biggest clients, we are looking for a Regulatory Affairs Specialist to join our teams in Spain.

Group 10

  • Develop local Spain Regulatory Affairs presence, taking responsibility for regulatory activities related to Spain, Europe and potentially LATAM for two of our biggest clients.
  • Contribute to the regulatory activities performed.  Regulatory activities include pre licensing activities, new registration (sites and medicinal products), post licensing regulatory submissions.
  • Compile regulatory dossiers in accordance with national requirements.
  • Contribute to the production of client administrative documents to be included in regulatory submissions
  • Preparation and submission of Technical/Site Transfer Applications
  • Document and track regulatory submissions and regulatory authority approval.
  • Monitor and maintain up-to-date knowledge of national and European guidelines/legislation.
  • Use a variety of software packages (Microsoft Office Suite, Veeva or comparable EDMS, LorenZ, Trackwise, etc) to produce correspondence and documents, maintain spreadsheets and databases, and locate information and data
  • 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.
  • 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)
  • Experience in the new registrations of drug products
  • Knowledge of Spanish and European regulations 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 management of artwork generation
  • Experience in promotional/non-promotional activities would be an advantage.
  • Fluency in Spanish. Portuguese is a plus.

Soft skills:

  • Good organizational skills
  • Good communication skills
  • A proven ability to consistently deliver to tight timelines, without negatively impacting on quality or departmental budget
  • Pro-active attitude and able to work on own initiative as well as part of a team
  • Ability to prioritize different workloads/multi-task
  • Personal responsibility for ensuring a high standard of work
  • Solution-driven

Regulatory Affairs Specialist - 766