Manager - Regulatory Affairs
October 1
Description
• Responsible for supporting regulatory strategy implementation for development programs • Collaborates to prepare regulatory submissions and support objectives • Contributes to developing global regulatory strategies • Maintains effective interactions with contributors and management • Tracks submissions and correspondence with health authorities
Requirements
• Bachelor’s or M.S./Ph.D. degree in scientific area • Minimum of 7 years’ experience with a Bachelor’s or 5 years’ experience with M.S./Ph.D. in relevant Regulatory Affairs • Minimum of 2 years supervisory experience • Experience and understanding of ICH, GCP, and FDA regulations • Experience in preparing regulatory submissions (US IND/NDA sequences) • Ability to work independently and within teams • Excellent written and oral communication skills • Strong organizational skills and ability to prioritize workload • Strong interpersonal skills
Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans (medical, dental, vision, basic life) • 20 days of PTO • 10 paid holidays • Winter company shutdown
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