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Global Regulatory Manager

2 months ago

Bracknell, Bracknell Forest, United Kingdom Allucent Full time
Global Regulatory Manager

At Allucent, we are dedicated to helping small-medium biopharmaceutical companies navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are seeking a highly skilled Global Regulatory Manager to join our team. The successful candidate will be responsible for managing regulatory activities, developing and implementing strategies for timely approvals, and ensuring the quality, content, and format of regulatory submissions.

Key Responsibilities:

  • Contribute to the development of regulatory strategies and plans
  • Coordinate the preparation and submission of regulatory documents
  • Ensure compliance with regulatory requirements and guidelines
  • Represent the company in interactions with regulatory authorities
  • Collaborate with cross-functional teams to ensure regulatory requirements are met

Requirements:

  • Bachelor's Degree in Healthcare or Biological Science and minimum 3 years of experience in drug development and/or clinical research
  • 5-10 years of Global Regulatory Submissions experience
  • Thorough knowledge of GxP, GDPR, EU CTR, and EU CTD and applicable local regulatory requirements
  • Strong written and verbal communication skills, including good command of English language
  • Strong organizational skills and ability to work in a fast-paced environment

Benefits:

  • Comprehensive benefits package
  • Competitive salaries
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours
  • Opportunity for remote/hybrid working
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training

Disclaimer:

Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles.