Regulatory Affairs Specialists
1 day ago
Estimated Salary: $85,000 - $110,000 per year.
Bicycle Therapeutics is a pioneering pharmaceutical company dedicated to developing innovative treatments for complex diseases. As a Senior Associate in Regulatory Affairs, you will play a critical role in shaping the company's regulatory strategy, ensuring compliance with global regulations and guidelines.
Responsibilities:- Regulatory Strategy Development: Collaborate with cross-functional teams to develop and implement regulatory strategies that support product development and commercialization.
- Regulatory Submission Management: Oversee the development and submission of regulatory documents, including INDs, CTAs, and marketing authorizations.
- Regulatory Compliance: Ensure compliance with FDA, EMA, and ICH guidelines, as well as other relevant regulations and standards.
- 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 understanding of regulatory affairs, excellent communication skills, and ability to work collaboratively in a fast-paced 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.
- Professional Growth Opportunities: Opportunities for career advancement and professional development within the company.
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