We are a biopharmaceutical company focused on unraveling the mysteries of the brain to treat neuroscience diseases.
201 - 500
March 29
We are a biopharmaceutical company focused on unraveling the mysteries of the brain to treat neuroscience diseases.
201 - 500
• Provide expertise in translating regulatory CMC requirements into innovative, efficient, and practical strategies • Partner with Global Regulatory Leads and Technical Operations Team lead for product strategy • Author Module 3 documentation for regulatory submissions • Review change controls to ensure regulatory compliance • Provide CMC regulatory guidance and implement internal documentation • Engage with Health Authorities contacts and Trade Associations for regulatory environment influence
• Minimum of 10 years experience in pharmaceutical/biotechnology industry with direct CMC Regulatory Affairs experience • Experience in preparing and submitting INDs, CTAs, and NDAs/Marketing Applications • Expert knowledge of GMP/ICH requirements in major markets • Excellent written and verbal communication skills • Ability to work collaboratively in cross-functional teams • BS scientific degree required, Master’s degree in relevant discipline preferred
• Opportunity to work in a cutting-edge company dedicated to treating neuroscience diseases • Chance to contribute to the development of breakthrough CNS therapies • Emphasis on trust, respect, courage, curiosity, and compassion in the culture • Patient-centric approach guiding purpose and everyday work • Opportunity to work with bold thinkers, deep experts, and resilient pathfinders • Greater Boston area headquarters
Apply NowMarch 29
11 - 50
March 20
1001 - 5000
🇺🇸 United States – Remote
💵 $245.2k - $288.5k / year
💰 $21.4M Post-IPO Equity on 2022-11
⏰ Full Time
🔴 Lead
🚔 Compliance
🗽 H1B Visa Sponsor