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.
Manager, Regulatory Affairs Submission Management in Thatcham employer: Carbon 60
At Carbon 60, we pride ourselves on fostering a collaborative and innovative work culture that empowers our employees to thrive. Located in Harlow, this hybrid role offers flexibility and the chance to engage with a dedicated Quality team, ensuring your contributions directly impact our commitment to quality excellence. With opportunities for professional growth and development, joining us means being part of a forward-thinking company that values your expertise and dedication.
