Quality Assurance Regulatory Affairs Manager

Manager - Regulatory Affairs Submission Management

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 lifecycle management of innovative healthcare products.

Key Responsibilities

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

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

Please click and submit your profile and/or to discuss further, contact Theo Charles on 07836 251472

*Umbrella also possible – please enquire for more information