Manager, Regulatory Affairs Submission Management

Manager – Regulatory Affairs Submission Management

Interested in this role You can find all the relevant information in the description below.

Contract: Temporary – 12 months (extension possible)

Location: Maidenhead – hybrid working (or remote if needed)

Rate: (INSIDE IR35)

circa. £22-25 per hour (PAYE)*

SRG are 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.

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.

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