Global Regulatory CMC Lead for LATAM

Moderna; Norwood (MA); Presencial; USD 143.000 - 257.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Healthcare

Well-being programs

Family planning benefits

Paid time off

Descripción de la vacante

Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions. This role oversees agency communications, and regulatory applications, coordinating cross-functional teams in a fast-paced environment.

The position demands extensive regulatory experience, strong LATAM knowledge, and the ability to manage multiple programs across vaccines, oncology, or rare diseases.

Formación

• BS in pharmaceutics, chemistry, chemical engineering or related field is required.
• MS degree in related field is desirable.
• 10+ years in pharma/biotech with manufacturing or analytical focus.
• 8+ years in biologics-focused regulatory CMC.
• Knowledge of LATAM regulations and cGMP.

Responsabilidades

• Develop and implement CMC regulatory strategies for LATAM post-approval submissions.
• Guide regulatory CMC aspects of product development projects.
• Review documents for submission readiness per health authority guidelines.
• Lead regulatory CMC discussions with health authorities to facilitate approvals.
• Develop processes to support CMC submissions and change controls.
• Guide manufacturing and quality teams on CMC regulatory matters.

Conocimientos

CMC regulatory strategy

Regulatory submissions

Regulatory guidance

Cross-functional leadership

Educación

BS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

MS in Pharmaceutics, Chemistry, Chemical Engineering, or closely related field

Descripción del empleo

Moderna seeks an Associate Director of Global Regulatory Affairs, CMC, to lead LATAM regulatory activities and ensure high-quality CMC submissions. This role oversees agency communications, and regulatory applications, coordinating cross-functional teams in a fast-paced environment.

The position demands extensive regulatory experience, strong LATAM knowledge, and the ability to manage multiple programs across vaccines, oncology, or rare diseases.