Director of Regulatory Affairs CMC

Job Title:Director, CMC Regulatory Processes and Systems

Location:London or Paris

Job Summary:

My Client is seeking a highly experienced professional to lead and optimize Chemistry, Manufacturing, and Controls (CMC) regulatory processes and systems. The Director will be responsible for initiating and maintaining CMC regulatory strategic plans across various assets, identifying team synergies or conflicts early, and proposing effective solutions.

Key Responsibilities:

• Develop and oversee the CMC regulatory strategic plan across multiple assets.​
• Identify and address team synergies and conflicts promptly, proposing effective solutions.​
• Ensure compliance with current regulatory guidelines and standards.​
• Collaborate with cross-functional teams to support regulatory submissions and approvals.​
• Continuously improve CMC regulatory processes and systems to enhance efficiency and effectiveness.​

Qualifications:

• Proven experience in CMC regulatory affairs within the pharmaceutical or biotechnology industry.​
• Strong leadership and project management skills.​
• Excellent communication and interpersonal abilities.​
• In-depth knowledge of global CMC regulatory requirements and guidelines.​
• Ability to work collaboratively in a fast-paced, dynamic environment.​

Application Process:

Interested candidates are invited to submit their resume and cover letter through our online application portal.