Manager - Regulatory Affairs
October 22
Description
• Responsible for supporting regulatory strategy implementation for development programs • Prepare regulatory submissions • Develop and implement global regulatory strategies • Maintain department regulatory processes • Develop partnerships internally and externally
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 Regulatory Affairs • Minimum of 2 years supervisory experience • Experience with ICH, GCP requirements, and FDA regulations • Experience in preparing regulatory submissions • Ability to work independently and within teams • Excellent written and oral communication skills • Strong organizational skills and interpersonal skills
Benefits
• Discretionary annual target bonus • Stock options • ESPP • 401k match • Top-notch health insurance plans • 20 days of PTO • 10 paid holidays • Winter company shutdown
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