Hub Submission Manager - Pharmaceutical Regulatory Operations
Location: Sandwich, Kent - Hybrid, 2.5 days onsite per week
Contract: 6 months
Pay Rate: Up to £17.67 per hour
Industry: Pharmaceutical / Regulatory Affairs
We are currently partnering with a leading global pharmaceutical organisation to recruit a Hub Submission Manager to support its Global Regulatory operations team.
This is an excellent opportunity for someone with experience in Regulatory Submissions, Regulatory Operations or Regulatory Publishing who is comfortable coordinating complex submission activities within a highly regulated pharmaceutical environment.
Key Responsibilities
- Coordinate regional and national regulatory submissions and dossiers
- Support initial applications and subsequent lifecycle submissions
- Manage submission planning, document receipt, technical build and delivery
- Coordinate electronic and paper submissions to Health Authorities
- Work closely with global project teams, country representatives and third-party partners
- Coordinate submission timelines and translation requirements
- Ensure submissions meet regulatory requirements, quality standards and deadlines
- Support document management, QC/QA and regulatory archiving
- Identify and resolve issues that could impact submission delivery
- Contribute to process improvements across regulatory submission activities
Experience We’re Looking For
- Previous experience within the pharmaceutical industry
- Experience in Regulatory Submissions, Regulatory Operations, Regulatory Publishing or Dossier Management
- Exposure to electronic regulatory submissions
- Understanding of regulatory dossiers and applicable filing guidelines
- Strong project coordination and organisational skills
- Excellent attention to detail
- Ability to work across multiple projects and tight deadlines
- Confident working with global and cross-functional stakeholders
- Good technical aptitude and ability to learn new regulatory systems and tools quickly
- Knowledge of the drug development process would be beneficial
A degree in Pharmacy, Life Sciences, Business or Information Technology is desirable, although equivalent relevant professional experience will also be considered.
This is a six-month onsite contract in Sandwich, Kent, paying up to £17 per hour.
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Hub Submission Manager / Medical writer employer: Atrium
Atrium is an exceptional employer that fosters a culture of growth and collaboration, making it an ideal place for a Catastrophe Analyst to thrive. With a commitment to flexible working arrangements and a strong focus on diversity, equity, and inclusion, employees are empowered to pursue their passions while contributing to meaningful work in the insurance industry. The opportunity to engage in innovative analytics development and support critical risk management initiatives ensures that team members play a vital role in shaping the future of the business.