Manager, Regulatory Affairs Submission Management

Carbon 60; Thatcham; Hybrid; GBP 63,038,976 - 71,635,200; Full time

Job summary

SRG in Maidenhead seeks a Regulatory Affairs professional with Submission Management experience to lead complex regulatory submissions for pharmaceutical products, supporting development, approval and lifecycle management.

This temporary 12‑month contract offers hybrid working in the UK (Maidenhead) or remote if needed, with an Inside IR35 PAYE rate of 22–25 GBP per hour. The role focuses on planning, publishing, quality reviews and process improvements within a cross‑functional team.

Qualifications

• Bachelor's degree or equivalent with relevant industry experience.
• Experience in pharmaceutical/biotech/regulated industry.
• Strong project management across cross-functional activities.
• Knowledge of submission operations and publishing processes.
• Excellent written and verbal communication; ability to influence stakeholders.
• Leadership including mentoring and driving process improvements; PMP/RAC advantageous.

Responsibilities

• Lead and manage complex regulatory submission projects, ensuring high-quality dossiers are delivered on time and in line with regulatory requirements.
• Act as the primary regulatory submission management contact for cross-functional project teams, providing guidance on processes, timelines, and deliverables.
• Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.
• Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.
• Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.
• Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.

Skills

Project management

Pharma experience

Regulatory operations

Communication skills

Leadership

PMP RAC advantage

Education

Bachelor's degree

Job description

Manager - Regulatory Affairs Submission Management

Overview

SRG is seeking a Regulatory Affairs professional with Submission Management skills & experience to assist a leading pharmaceutical company on a temporary basis. Join a dynamic regulatory affairs team and play a pivotal role in delivering complex regulatory submissions that support the development, approval, and life‑cycle management of innovative healthcare products.

Contract Details

• Contract: Temporary – 12 months (extension possible)
• Location: Maidenhead – hybrid working (or remote if needed)
• Rate: Inside IR35 – circa £22‑25 per hour (PAYE)

Key Responsibilities

• Lead and manage complex regulatory submission projects, ensuring high‑quality dossiers are delivered on time and in line with regulatory requirements.
• Act as the primary regulatory submission management contact for cross‑functional project teams, providing guidance on processes, timelines, and deliverables.
• Coordinate and facilitate submission planning meetings, driving progress across multiple concurrent projects and stakeholders.
• Oversee publishing activities and collaborate with external publishing partners to ensure successful submission delivery.
• Perform quality reviews of published submissions, ensuring compliance with technical standards and regulatory authority requirements.
• Contribute to continuous improvement initiatives, enhancing regulatory processes, standards, and systems.

Skills & Experience Required

• Bachelor's degree or equivalent combination of education and relevant industry experience.
• Experience within the pharmaceutical, biotechnology, healthcare, or related regulated industry.
• Strong project management skills, with experience managing complex, cross‑functional activities and competing priorities.
• Knowledge of regulatory operations, submission management, and/or submission publishing processes.
• Excellent written and verbal communication skills, with the ability to influence stakeholders in a matrix environment.
• Demonstrated leadership capability, including mentoring colleagues and driving process improvements. PMP and/or RAC certification is advantageous.

How to Apply

To apply, click and submit your profile or contact Theo Charles for further discussion.