Associate Director, Regulatory Operations

Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. We develop medicines for previously untreatable or undertreated diseases and provide meaningful support for healthcare providers and patients and their families.

Requirements

• Bachelor’s degree in life/physical sciences or related field
• 8+ years of highly relevant pharmaceutical/biotechnology experience in Regulatory Affairs Operations
• Knowledge and understanding of the drug development process
• Strong knowledge of FDA and Global EU/UK regulations and guidelines, especially CTD and eCTD structure
• Experience with Veeva RIM EDMS
• Highly proficient in Microsoft Office suite
• Ability to balance both strategic and operational approaches, ‘think outside the box’ and to manage multiple tasks in a fast-paced environment
• Detail-oriented and highly organized
• Excellent interpersonal skills and ability to develop collaborative partnerships with key stakeholders

Benefits

• Discretionary annual bonus
• Benefits
• Restricted stock units