GRA CMC Lead

Role Summary

GRA CMC Lead based in Morristown, NJ. You will drive global regulatory strategies for pharmaceutical and vaccine products within the GRA CMC organization, collaborate with cross-functional teams to navigate regulatory landscapes, optimize development and manufacturing processes, and influence drug approvals through strategic interactions with health authorities worldwide.

Responsibilities

• Shape the Future of Medicine: Develop smart regulatory strategies for products from early development to market and interact with health authorities like FDA and EMA.
• Be a Problem Solver: Identify regulatory challenges early and develop practical solutions.
• Build Strong Relationships: Collaborate across R&D, Manufacturing, and Quality to drive success.
• Make Smart Decisions: Assess risks and opportunities to balance innovation with compliance.
• Drive Quality: Review technical documents and provide strategic guidance to regulatory submissions.
• Stay Ahead of Changes: Monitor evolving regulations and industry trends to anticipate new requirements.
• Lead with Impact: Influence product development strategies while growing expertise in a supportive, inclusive environment.

Qualifications

• Experience: Minimum 4+ years of CMC regulatory experience with contributions to regulatory filings and implementation of regulatory strategies; experience responding to Health Authority questions.
• Education: Bachelor's degree in a scientific discipline (Chemistry, Biology, Pharmacy, or related field).
• Regulatory Expertise: Experience preparing regulatory documentation and familiarity with standard submission processes.
• Technical Knowledge: Understanding of pharmaceutical development, manufacturing processes, and regulatory requirements in major markets.
• Collaboration Skills: Ability to work effectively in a matrix environment, engaging cross-functionally with R&D, Manufacturing, and Quality teams.
• Communication: Strong written and verbal communication skills, with fluency in English.
• Adaptability: Ability to manage multiple projects in a fast-paced, hybrid work environment (60% on-site).

Skills

• Regulatory strategy development for pharmaceuticals and vaccines
• Cross-functional collaboration (R&D, Manufacturing, Quality)
• Regulatory submissions and liaison with health authorities (FDA, EMA)
• Risk assessment and regulatory trend analysis
• Technical document review and quality guidance
• Written and verbal communication in English

Education

• Bachelor's degree in Chemistry, Biology, Pharmacy, or related scientific field

Additional Requirements

• Hybrid work environment with on-site presence required (approximately 60%)