Regulatory Affairs Associate

Contract

• The role is for 12 months and is renewable.
• Employment is outsourced through ManpowerGroup.

Job purpose

Regulatory plan and submissions

• Collaborate on the Regulatory Plan in alignment with affiliate business plans and regulatory requirements.
• Support high-quality regulatory applications within planned timelines and prepare dossiers for new marketing authorizations.
• Coordinate translations, legalizations, and other administrative tasks needed for dossier preparation.
• Submit renewals, variations, periodic reports, and other post-approval maintenance activities on time.
• Assemble dossiers according to local regulations and quality-system requirements.

Compliance and labelling

• Keep regulatory IT tools, archives, current licenses, and labels accurate and up to date.
• Ensure products meet applicable local regulatory and quality-system requirements, and support the local quality system.
• Support audits, assessments, and self-inspections with Regulatory Quality personnel; raise compliance issues with relevant functions.
• Serve as Primary, Delegate, or Alternate Affiliate Labelling Responsible Person and ensure product information meets local requirements and internal or Ministry of Health timelines.
• Follow global labelling procedures, document relevant exceptions, and maintain accurate product information on the eLabelling website.

Process and development

• Support relevant internal regulatory initiatives.
• Maintain awareness of local, regional, and global regulatory procedures and upcoming changes; communicate and implement applicable changes locally.
• Attend external regulatory training or Ministry of Health meetings focused on local regulations when available.

Minimum qualifications and preferences

• Bachelor's degree in pharmacy or an equivalent degree in a relevant scientific subject.
• Good communication and computer/IT skills.
• Good written and spoken English.
• Previous experience is highly regarded, but no minimum experience requirement is stated.
• Adaptability, teamwork, results focus, time management, and positive networking skills are listed as additional preferences.