Hub Submission Manager

The Opportunity - based in Tadworth, UK, on-site full time

This is a high-impact, globally facing role at the centre of regulatory operations. You’ll be responsible for driving the delivery of complex regulatory submissions across multiple markets, playing a key part in bringing products to market and maintaining global compliance.

If you thrive in fast-paced environments, enjoy coordinating across international teams, and want real ownership in submission delivery, this is a standout opportunity.

Key Responsibilities

• Own the end-to-end delivery of regulatory submissions for assigned products, covering both initial applications and lifecycle activities
• Lead the coordination of cross-functional teams to ensure submissions are delivered on time, to quality, and in line with regulatory expectations
• Manage all operational aspects of submissions including planning, document flow, translation strategy, technical build, and final delivery to Health Authorities
• Act as the central interface between global project teams and regional/country stakeholders, aligning on timelines, requirements, and compliance standards
• Ensure all submission activities adhere to global regulatory frameworks, internal processes, and quality standards
• Identify and drive opportunities to improve efficiency, including dossier re-use, process optimisation, and global standardisation
• Escalate and resolve risks that may impact submission timelines or quality

At Manager level, you will also:

• Lead more complex, multi-market submissions and process improvement initiatives
• Interpret regulatory requirements and translate them into operational delivery plans
• Influence and guide stakeholders across functions in a matrix environment
• Forecast and manage resources across multiple concurrent projects
• Act as a technical expert for submission processes and systems

At Senior Manager level, you will additionally:

• Drive strategic improvements across submission delivery and regulatory operations
• Lead cross-functional initiatives focused on innovation, efficiency, and scalability
• Represent the organisation in external regulatory or industry discussions
• Contribute to policy, process, and capability development across the function
• Mentor and develop team members, acting as a senior technical authority

Why This Role Stands Out

• High visibility role with direct impact on global product submissions and approvals
• Exposure to multiple regions, regulatory frameworks, and product portfolios
• Clear progression from operational delivery into leadership and strategy
• Opportunity to shape how submissions are executed, scaled, and optimised globally
• Collaborative, international environment with strong cross-functional engagement

Skills & Experience

Proven experience in a pharmaceutical or life sciences regulatory environment

Strong background in regulatory submissions and lifecycle management

Solid project management capability, with experience handling multiple complex deliverables

High attention to detail and ability to work to tight deadlines in regulated settings

Confident communicator, able to engage and influence across global teams

Experience with electronic submissions, dossier structures, and regulatory systems

For more senior levels:

• Deep understanding of regulatory sciences and global submission processes
• Experience leading projects and driving process improvements
• Ability to influence, mentor, and operate effectively within a matrix structure
• Strong problem-solving skills and ability to make decisions in complex or ambiguous situations

Qualifications

• Degree in Life Sciences, Pharmacy, Business, IT, or related discipline (or equivalent experience)
• Demonstrated technical aptitude and ability to learn new systems and regulatory requirements quickly
• Experience with document management systems and submission technologies is highly desirable
• Additional language skills are advantageous

Stakeholder Environment

Work closely with global regulatory teams, project teams, and regional representatives

Engage with external vendors, partners, and Health Authorities where required

Operate across multiple regions, cultures, and time zones

Resource Responsibility

Manage project-specific resources, coordinating internal teams and external suppliers

Ensure submissions are delivered efficiently, on time, and in full regulatory compliance