Principal Professional, Regulatory Affairs CMC (Ballerup)

Job summary

This role involves providing strategic leadership and operational support in Regulatory Affairs, specifically focusing on Chemistry, Manufacturing, and Controls (CMC) for early development programs. The position is based in Ballerup, Denmark, and is not remote.

Qualifications

• Master’s or Bachelor’s degree in pharmaceutics, biomedicine, chemical engineering, or a related scientific field.
• Over 8 years of experience in Regulatory Affairs, particularly in CMC for biologics, with additional experience in small molecules being advantageous.
• Proven experience in preparing and submitting CMC/device documents for global markets.
• Strong understanding of drug development processes and global CMC guidelines.

Responsibilities

• Lead CMC regulatory input for Global Regulatory Strategy in collaboration with relevant stakeholders.
• Facilitate Health Authority interactions and prepare necessary regulatory documentation for Clinical Trials.
• Identify program issues and develop strategies to mitigate risks to regulatory filings.
• Ensure regulatory dossiers are flexible for post-approval planning and operations.
• Provide regulatory advice on Change Control cases and mentor colleagues.

Skills

• Strong problem-solving and risk mitigation skills.
• Excellent communication and negotiation abilities for cross-functional alignment.
• Strategic mindset with the ability to manage complex regulatory projects.

Education

• Master’s or Bachelor’s degree in a relevant scientific field.

Tools

• Familiarity with regulatory submission tools and documentation processes.