US Trade Licensing & Compliance Analyst
Bristol Myers Squibb
Global Regulatory Affairs CMC Lead
Sanofi
full-time
Posted on:
Location Type: Hybrid
Location: Framingham • Massachusetts, New Jersey • 🇺🇸 United States
Visit company websiteSalary
💰 $122,250 - $176,583 per year
Job Level
Senior
About the role
- develop and implement global regulatory CMC strategies
- create strategies for development and marketed products
- focus on chemical entities, biological entities, and/or vaccine products
- execute and adapt strategies as needed
- serve as the primary point of contact for regulatory authorities
- act as direct liaison with agencies like US FDA and EMA
- develop positive relationships with regulators
- support strategic negotiations with worldwide Regulatory Health Authorities
- manage CMC documentation and submissions
- write, prepare, review, and approve regulatory CMC dossiers
- ensure dossiers meet quality standards
- comply with regulatory requirements
- maintain documentation accuracy and completeness
- lead cross-functional collaboration
- work closely with R&D Functions
- collaborate with Manufacturing & Supply Functions
- coordinate with GRA Regulatory Operations
- ensure effective implementation of regulatory strategies
- facilitate resolution of CMC issues
- identify and manage regulatory risks
- assess regulatory CMC opportunities and risks
- develop risk mitigation strategies
- communicate implications to project teams
- articulate risk/benefit components to stakeholders
- contribute to regulatory science and policy activities
- monitor local and international Health Authority regulations and guidelines
- participate in the review process for new regulations
- anticipate potential regulatory paradigm shifts
- track and communicate current Health Authority thinking and trends
Requirements
- 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies
- experience responding to Health Authority questions
- experience preparing regulatory documentation and familiarity with standard submission processes
- understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets
- ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams
- Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field)
- strong written and verbal communication skills, with fluency in English
- capability to manage multiple projects in a fast-paced, hybrid work environment
Benefits
- high-quality healthcare
- prevention and wellness programs
- at least 14 weeks’ gender-neutral parental leave
- structured career paths for advancement
- flexible working options
- comprehensive well-being programs
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
CMC regulatory experienceregulatory filingsregulatory strategiesregulatory documentationsubmission processespharmaceutical developmentmanufacturing processesregulatory requirementsrisk mitigation strategiesregulatory CMC dossiers
Soft skills
strong written communicationstrong verbal communicationcross-functional collaborationrelationship managementproject managementnegotiation skillsproblem-solvingadaptabilitystakeholder communicationmatrix environment engagement
Certifications
Bachelor's degree in ChemistryBachelor's degree in BiologyBachelor's degree in Pharmacy
