CGT Regulatory Affairs Director, CMC (Remote)

Miltenyi-Biomedicine,-Inc.; Baltimore (MD); Remoto; USD 250.000 - 272.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

401(k) plan

Descrizione del lavoro

Miltenyi Biomedicine Inc. in Baltimore, MD is seeking a Sr Director of Regulatory Affairs CMC to lead a global team and drive regulatory strategies for Cell & Gene Therapy (CGT) products.

You will oversee submissions, interact with health authorities, and ensure compliance across development and commercialization stages. The role requires extensive CMC regulatory experience, leadership excellence, and strong collaboration with manufacturing, quality, and clinical development teams to advance

Competenze

• Master’s degree or PhD in Pharmacy, Biotechnology, Biology, Chemistry or related scientific discipline.
• 12+ years hands-on experience in Chemistry, Manufacturing & Controls (CMC) Regulatory Affairs for CGT products.
• Extensive experience supporting global regulatory submissions and health authority interactions (EU/US).
• Deep understanding of biologics, ATMPs, CGT products and global regulatory frameworks.
• Excellent communication, leadership and project management skills.
• Fluent English written and verbal communication.

Mansioni

• Lead a global team of CMC RA managers and serve as the regulatory expert for CGT product programs.
• Develop and review CMC regulatory strategies for submissions including INDs, CTAs, BLAs and MAAs.
• Provide strategic guidance on regulatory requirements for manufacturing processes, analytics, specifications and control strategies.
• Assess regulatory impact of manufacturing changes and determine worldwide regulatory pathways.
• Support interactions with health authorities (FDA, EMA, MHRA) in collaboration with local RA teams.
• Collaborate with Process Development, Manufacturing, Quality, Supply Chain and Clinical Development functions.
• Monitor regulatory developments and translate them into actionable regulatory strategies.
• Drive regulatory risk assessments and mitigation plans across the product lifecycle.

Conoscenze

Leadership

Communication

Project management

Formazione

Master’s degree or PhD in a related scientific discipline

Descrizione del lavoro

Miltenyi Biomedicine Inc. in Baltimore, MD is seeking a Sr Director of Regulatory Affairs CMC to lead a global team and drive regulatory strategies for Cell & Gene Therapy (CGT) products.

You will oversee submissions, interact with health authorities, and ensure compliance across development and commercialization stages. The role requires extensive CMC regulatory experience, leadership excellence, and strong collaboration with manufacturing, quality, and clinical development teams to advance