SRG
Quality Assurance Regulatory Affairs Manager
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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
- 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.
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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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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
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