Regulatory Affairs Specialist

We are looking for an experienced Regulatory Affairs Specialist to support management and continuous improvement of regulatory processes. 

Key Responsibilities

• Preparation, review, and submission of variations to Marketing Authorizations (MAs), including safety-related variations, ensuring alignment with EU and national regulatory requirements.
• Oversee the tracking and management of regulatory deadlines, with a focus on proactive monitoring of product lifecycle management.
• Manage company licence variations in coordination with internal stakeholders and authorities.
• Contribute to and lead initiatives in regulatory process design, optimization, and documentation, including authoring and maintaining SOPs. 
• Act as a point of contact for cross-functional projects impacting regulatory compliance, including audits, inspections, and quality management reviews.
• Maintain and improve internal tracking systems and regulatory databases. 

Candidate Profile

• Education: Master's degree in Pharmacy, Life Sciences, or a related field. 
• Experience: Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry. 
• Skills: 
  • Strong understanding of regulatory frameworks, including EU Variation Regulations, the HMA/CMDh guidelines, and national requirements.
  • Demonstrated experience with safety variations and regulatory lifecycle planning.
  • Ability to draft and implement regulatory SOPs, procedures, and internal workflows.
  • Strong organizational and project management skills, with attention to detail and a solutions-oriented approach
  • Applicant must be in possession of a valid work permit.

Benefits

• Competitive remuneration package;
• Comprehensive health insurance;
• Hybrid working arrangements;
• Safe and conducive working environment;
• On-the-job training and professional development in a state-of-the-art facility equipped with the latest technologies.