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Regulatory Affairs Expert

2 months ago

Boston, Massachusetts, United States Foundation Medicine Full time
Regulatory Affairs Specialist

The Senior Specialist, Regulatory Affairs plays a critical role in supporting the regulatory submissions process at Foundation Medicine. This involves developing regulatory strategies and submitting materials to health authorities such as the FDA for approval of novel platforms.

Key Responsibilities:
  • Develop and implement regulatory strategies to support product submissions
  • Prepare and submit regulatory documents to health authorities
  • Collaborate with cross-functional teams to ensure regulatory compliance
  • Stay up-to-date with changing regulatory requirements and guidelines
Requirements:
  • Strong understanding of regulatory affairs and compliance
  • Excellent communication and project management skills
  • Ability to work in a fast-paced environment and prioritize multiple tasks
  • Strong analytical and problem-solving skills