Hybrid Manager, Regulatory Registration Requirements – Submission Delivery Excellence

Posted 2 weeks ago

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About the role

  • Manager managing regulatory registration requirements for health authority submissions across multiple markets. Collaborating with cross-functional teams to ensure compliance with global standards and drive improvements.

Responsibilities

  • Manage end-to-end preparation of regulatory registration requirements for health authority submissions
  • Coordinate with cross-functional teams to execute regulatory submission strategies
  • Mentor and develop team members
  • Ensure compliance with global regulatory standards
  • Drive continuous improvement and system innovation

Requirements

  • Bachelor’s degree or higher in pharmaceutical, biological or healthcare science
  • Significant relevant regulatory/submission experience with local health authorities
  • Strong understanding of international regulations
  • In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing
  • Strong awareness of GMP principles
  • Ability to interpret regulations and gain consensus on a way forward
  • Strong written and verbal communication skills
  • Demonstrated agility in adapting to rapidly changing priorities and timelines

Benefits

  • competitive salary
  • an annual bonus based on company performance
  • healthcare and wellbeing programmes
  • pension plan membership
  • shares and savings programme

Job title

Manager, Regulatory Registration Requirements – Submission Delivery Excellence

Job type

Experience level

Mid levelSenior

Salary

PLN 198,000 - PLN 330,000 per year

Degree requirement

Bachelor's Degree

Location requirements

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