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Global Regulatory Manager
2 months ago
We are seeking a highly skilled Global Regulatory Manager to join our team at Allucent. As a key member of our organization, 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 Responsibilities- Contribute to the development of regulatory strategies and plans for clinical trials.
- Develop and implement procedures for ensuring compliance with regulatory requirements.
- Coordinate the preparation and submission of regulatory documents, including amendments and responses to regulatory agency inquiries.
- Plan and manage timelines for regulatory submissions and approvals.
- Act as a subject matter expert for regulatory requirements and provide guidance to internal stakeholders.
- Represent Allucent in interactions with regulatory agencies and reviewers.
- Collaborate with cross-functional teams to ensure regulatory compliance and quality.
- Bachelor's degree in a relevant field, such as healthcare or biological science.
- Minimum 3 years of experience in drug development and/or clinical research.
- 5-10 years of experience in global regulatory submissions.
- Thorough knowledge of GxP, GDPR, EU CTR, and EU CTD regulations.
- Strong written and verbal communication skills, including good command of the English language.
- Strong organizational skills and ability to work in a fast-paced environment.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- Flexible working hours and remote work options.
- Access to online training and development resources.
- Eligibility for spot bonus and loyalty award programs.