Manager, Regulatory Affairs Submission Management

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 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.To Apply

Please click and submit your profile and/or to discuss further, contact Theo Charles on (phone number removed)

*Umbrella also possible - please enquire for more information

Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy