Senior Manager, Vaccines CMC RA Business Introduction Position Summary Responsibilities

GSK; City Of London; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

A leading global healthcare company is seeking an experienced professional to lead CMC regulatory strategies for vaccines. This role requires a Bachelor's degree and significant experience in regulatory affairs. Responsibilities include developing regulatory compliance strategies and mentoring team members. The position offers a hybrid working model based in the UK, fostering collaboration across teams.

Qualifications

• At least 6 years of experience in CMC regulatory affairs.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proven ability to manage multiple projects and meet deadlines.

Responsibilities

• Lead and deliver CMC regulatory strategies for vaccines.
• Prepare and review technical regulatory documents.
• Provide regulatory advice to cross-functional teams.

Skills

Regulatory compliance

Project management

Communication skills

Collaboration

Education

Bachelor's degree in life sciences, pharmacy or chemistry

Job description

Overview

This role offers an exciting opportunity to lead and deliver Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for vaccines. You will manage global CMC regulatory activities across development, registration, and lifecycle management. Collaboration is key, as you\'ll work closely with cross-functional teams to ensure compliance and drive innovation. We value candidates who are proactive, detail-oriented, and skilled at navigating complex regulatory environments.

Location and model: This role is based in Belgium and offers a hybrid working model, combining on-site and remote work flexibility.

Responsibilities

• Lead and deliver CMC regulatory strategies for vaccines across development, registration, and lifecycle management, collaborating with cross-functional teams to ensure compliance and drive innovation.
• Develop and implement CMC regulatory strategies 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

• Bachelor\'s degree in life sciences, pharmacy, chemistry, or a related field.
• At least 6 years of experience in CMC regulatory affairs.
• Strong knowledge of global CMC regulatory requirements and drug development processes.
• Proven ability to manage multiple projects and meet deadlines.
• Excellent communication and collaboration skills.

Preferred

• Master\'s degree or PhD in a relevant scientific discipline.
• Regulatory Affairs Certification (e.g., RAPS).
• Experience leading teams and managing complex regulatory submissions.
• Track record of effective negotiation with regulatory agencies.
• Fluency in English; proficiency in French is a plus.