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Global Regulatory Manager
2 months ago
As a Global Regulatory Manager at Allucent, you 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 Tasks- Contribute to the development of regulatory plans and strategies
- Coordinate the preparation of regulatory submissions, including amendments
- Plan realistic timelines for submissions and approvals
- Act as a source of information for sponsors, senior leadership, and other stakeholders on regulatory requirements
- Represent the company in interactions with regulatory authorities
To be successful in this role, you will possess:
- Bachelor's degree in a relevant field 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
As a Global Regulatory Manager at Allucent, you will enjoy a comprehensive benefits package, competitive salary, and opportunities for professional development and growth.
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