Global Compliance Leads
2 days ago
Estimated Salary: $85,000 - $110,000 per year.
Bicycle Therapeutics is a cutting-edge pharmaceutical company focused on developing novel therapies for challenging diseases. As a Senior Associate in Regulatory Affairs, you will contribute to the development and implementation of regulatory strategies, ensuring compliance with global regulations and guidelines.
Main Responsibilities:- Regulatory Planning: Develop and execute regulatory plans to support product development, ensuring alignment with company goals and objectives.
- Regulatory Submission Preparation: Prepare and submit regulatory documents, including INDs, CTAs, and marketing authorizations, in collaboration with cross-functional teams.
- Regulatory Compliance Monitoring: Monitor and report on regulatory compliance, ensuring adherence to FDA, EMA, and ICH guidelines.
- Education: Bachelor's degree in a scientific field or post-graduate degree preferred.
- Experience: Minimum 2 years experience in the pharmaceutical or biotechnology industry.
- Skills: Strong analytical skills, excellent communication skills, and ability to work collaboratively in a dynamic environment.
- Competitive Salary: $85,000 - $110,000 per year.
- Flexible Working Environment: State-of-the-art campus environment with on-campus restaurant and Montessori nursery.
- Opportunities for Growth: Opportunities for career advancement and professional development within the company.
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