Senior Manager, Vaccines CMC RA

Role Summary

Lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. Manage global CMC regulatory activities across development, registration, and lifecycle management. Collaborate with cross-functional teams to ensure compliance and drive innovation. Based in Belgium with hybrid on-site and remote work.

Responsibilities

• Develop and implement CMC regulatory strategies for vaccines, ensuring compliance with global standards.
• Prepare and review technical regulatory documents to support submissions and lifecycle management.
• Provide regulatory advice to cross-functional teams, including R&D, manufacturing, and quality assurance.
• Lead discussions with regulatory authorities and represent the company in external engagements.
• Identify risks and propose mitigation strategies to ensure smooth regulatory processes.
• Mentor and train team members, fostering a culture of continuous improvement.

Qualifications

• Required: At least 6 years of experience in CMC regulatory affairs.
• Required: Strong knowledge of global CMC regulatory requirements and drug development processes.
• Required: Proven ability to manage multiple projects and meet deadlines.
• Required: Excellent communication and collaboration skills.
• Preferred: Master’s degree or PhD in a relevant scientific discipline.
• Preferred: Regulatory Affairs Certification (e.g., RAPS).
• Preferred: Experience leading teams and managing complex regulatory submissions.
• Preferred: Track record of effective negotiation with regulatory agencies.
• Preferred: Fluency in English; proficiency in French is a plus.

Education

• Bachelor’s degree in life sciences, pharmacy, chemistry, or a related field.