CMC Regulatory Affairs Director

We are seeking a highly experienced CMC Regulatory Affairs Director to join our team at TOBLOR Consulting. As a key member of our organization, you will be responsible for leading the CMC Regulatory Affairs team and providing strategic guidance on regulatory compliance and strategy.

• Develop and implement CMC regulatory strategies for pharmaceutical products and development projects.
• Lead and manage the CMC Regulatory Affairs team, providing guidance and support to ensure compliance with regulatory requirements.
• Collaborate with cross-functional teams to ensure alignment on regulatory strategies and compliance.
• Prepare and present regulatory documents and submissions to health authorities.
• Stay up-to-date with regulatory changes and developments, providing guidance and recommendations to the team.

• Minimum 5 years of experience in CMC Regulatory Affairs, preferably in a global regulatory team.
• Profound knowledge of CMC regulatory requirements and guidelines.
• Excellent communication and documentation skills, with proficiency in English.
• Project management skills and ability to work in a fast-paced environment.
• Strong leadership and team management skills, with a focus on developing and mentoring team members.

As a CMC Regulatory Affairs Director at TOBLOR Consulting, you will have the opportunity to work with a dynamic and innovative team, driving regulatory compliance and strategy for pharmaceutical products. We offer a competitive salary and benefits package, as well as opportunities for professional growth and development.