Global Regulatory Affairs Manager (On-site, Copenhagen)

Job summary

This role involves managing regulatory affairs within the Gastro portfolio at a pharmaceutical company for a 12-month contract. The position is based at the Ferring International PharmaScience Center in Kastrup, Copenhagen, and focuses on lifecycle management activities and projects.

Qualifications

• Degree in life science or pharmacy
• Experience in global regulatory affairs, particularly in regulatory CMC activities and development projects
• Familiarity with CMC documentation and global variation packages
• Excellent verbal and written communication skills
• Proactive mindset with a focus on innovative regulatory solutions
• Strong team player with a positive impact on the work environment

Responsibilities

• Oversee CMC aspects of regulatory submissions and approvals for global market expansions and renewals
• Provide regulatory CMC strategies and expertise to cross-functional teams
• Conduct regulatory impact assessments of CMC changes for established products and ensure timely documentation submission and approval
• Actively participate in the development and optimization of departmental processes

Skills

• Strong organizational skills for planning and executing projects
• Ability to meet deadlines and represent GRA CMC in cross-functional teams

Education

• Degree in life science or pharmacy

Tools

• Familiarity with regulatory submission tools and documentation processes