Principal Scientist, Regulatory Affairs – CMC

• Develop and implement CMC regulatory strategies for pharmaceutical products in accordance with global regulations, guidance, and company procedures
• Lead preparation and submission of CMC dossiers supporting global market applications
• Serve as CMC Product Lead for new small-molecule and peptide pharmaceutical products
• Deliver regulatory milestones throughout product development, including assessing regulatory success probability and mitigation measures
• Lead Regulatory CMC discussions and interactions with regulatory agencies
• Provide regulatory leadership, oversight, and strategy to matrixed Regulatory CMC teams
• Prepare INDs/CTAs, Agency Background Packages, and Worldwide Marketing Applications, including Most of World applications
• Provide regulatory leadership for product in-licensing and due-diligence reviews
• Manage CMC documentation execution, including IND/CTA, original NDA/MAA, agency background packages, and responses to health-authority questions
• Identify, communicate, and escalation potential regulatory issues to GRACS CMC management
• Evaluate and develop team talent and prepare succession plans
• Support approval and launch market supply of pharmaceutical products worldwide
• Conduct all activities with a focus on compliance

• B.S. in biological science, engineering, or a related field; advanced degree preferred
• 5–10 years of pharmaceutical development experience, including biological/pharmaceutical research, manufacturing, testing, regulatory CMC, or related fields
• At least 7 years of experience in Regulatory CMC roles
• Experience leading preparation of NDA/MAA CTD content
• Proven experience in regulatory CMC with strong technical leadership skills
• Understanding of pharmaceutical operations, including manufacturing, process development, analytical, and quality assurance
• Experience critically reviewing detailed scientific information and assessing technical arguments and supporting data Experience defining global CMC strategy
• Subject matter expertise in a pharmaceutical-related discipline
• Superior oral and written communication skills in multicultural settings
• Ability to lead direct or matrixed colleagues and deliver business commitments and project timelines
• Proficiency in English; additional language skills are a plus
• No visa sponsorship available
• Must be a US or Puerto Rico resident
• No valid driving license required

Demonstrates expertise in developing and implementing CMC regulatory strategies for pharmaceutical products, with a strong focus on compliance and leadership in regulatory submissions and interactions. Proven ability to manage CMC documentation and lead cross-functional teams to achieve regulatory milestones.

• Regulatory CMC Strategy Development
• NDA/MAA Preparation
• Pharmaceutical Operations Knowledge
• Technical Leadership in Regulatory CMC
• Multicultural Communication Skills

• CMC Regulatory Strategy
• IND Preparation
• NDA/MAA Submission
• Pharmaceutical Development
• Regulatory Compliance
• Scientific Information Review
• Global CMC Strategy
• Pharmaceutical Manufacturing
• Process Development
• Quality Assurance

• Leadership
• Communication
• Team Management
• Problem-Solving
• Talent Development

• Pharmaceutical Products
• Regulatory Agencies
• CMC Dossiers
• Market Applications
• Due-Diligence Reviews
• Health-Authority Questions
• Biological Science
• Engineering
• Multicultural Settings
• US or Puerto Rico Resident