Principal Regulatory Affairs Professional (Pharmaceuticals, Remote)

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 requires collaboration with various stakeholders to define regulatory strategies and ensure timely approvals for submissions.

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 track record in supporting combination products through development and approval processes.
• Strong background in preparing and submitting CMC/device documents for global markets.
• Experience in drug development processes and lifecycle management, with a strategic mindset.

Responsibilities

• Lead CMC regulatory input for Global Regulatory Strategy in collaboration with relevant teams.
• Facilitate Health Authority interactions and prepare necessary regulatory documentation for Clinical Trials.
• Identify program issues and develop strategies to mitigate risks to filings.
• Ensure regulatory dossiers are flexible for post-approval planning and operations.
• Stay updated with Regulatory Intelligence and provide insights for CMC strategies.
• Mentor colleagues and participate in cross-functional improvement projects.

Skills

• Excellent communication, negotiation, and interpersonal skills.
• Strong problem-solving and critical thinking abilities.
• Experience in cross-functional collaboration with Regulatory Affairs, Product Supply, and Quality teams.

Education

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

Tools

• Familiarity with global CMC guidelines and regulatory requirements.