Hub Submissions Manager

Next Phase Recruitment; Stone Cross; On-site; GBP 45,000 - 75,000; Full time

Job summary

Next Phase Recruitment seeks a Regulatory Submissions Specialist to manage the global submission lifecycle for pharmaceutical products. You will oversee end-to-end delivery, coordinate cross-functional teams, and ensure timelines and quality align with regulatory expectations.

The role requires a life sciences or related degree, plus regulatory operations experience, strong project management, attention to detail, and proficiency with submission systems.

Qualifications

• Degree in Life Sciences, Pharmacy, Business, IT, or related discipline.
• Experience in regulatory submissions or regulatory operations within pharma or life sciences.
• Strong project management and coordination skills.
• Excellent attention to detail and ability to manage multiple complex deliverables.
• Proficiency with electronic submission systems, dossier structures, and regulatory tools.
• Senior level: leadership experience, deep understanding of submission processes, and mentoring others.

Responsibilities

• Oversee end-to-end delivery of regulatory submissions for assigned products.
• Coordinate cross-functional teams to meet submission timelines and quality expectations.
• Manage planning, document flow, translations, and submission build.
• Act as the connection between global, regional, and local teams to align on regulatory requirements.
• Drive process optimisation and continuous improvement initiatives.
• Senior level: lead cross-functional strategic projects, represent the organisation in global discussions, contribute to policy and process development.

Skills

Regulatory submissions

Project management

Stakeholder engagement

Attention to detail

Team coordination

Education

Degree in Life Sciences or related discipline

Tools

Regulatory submission systems

Electronic publishing tools

Regulatory information management tools

Job description

Qualifications & Experience

• Degree in Life Sciences, Pharmacy, Business, IT, or related discipline
• Demonstrated experience in regulatory submissions or regulatory operations within the pharmaceutical or life sciences industry
• Strong project management and coordination skills
• Excellent attention to detail and ability to manage multiple complex deliverables
• Proficiency with electronic submission systems, dossier structures, and regulatory tools
• For senior levels: proven leadership experience, deep understanding of submission processes, and ability to mentor others

Responsibilities

In this role, you will play a pivotal part in managing the global regulatory submission lifecycle:

• Oversee end-to-end delivery of regulatory submissions for assigned products
• Coordinate cross-functional teams to meet submission timelines and quality expectations
• Manage operational aspects such as planning, document flow, translations, and submission build
• Act as the connection between global, regional, and local teams to align on regulatory requirements
• Drive process optimisation and continuous improvement initiatives
• For senior levels: lead cross-functional strategic projects, represent the organisation in global discussions, and contribute to policy and process development

Skills / Technical Competencies

• Proficiency in submission management systems and electronic publishing tools
• Deep understanding of global regulatory frameworks
• Strong communication and stakeholder engagement across international teams
• Analytical mindset with the ability to work under pressure and deliver to tight deadlines
• Capability to influence, mentor, and drive best practices within matrix environments

Nice to Haves

• Experience with document management systems or regulatory information management tools
• Additional language skills for global coordination
• Background in process improvement or digital transformation in regulatory operations