Regulatory CMC Leader — Global Submissions & Strategy

Syneos Health, Inc.; Massachusetts; Presencial; USD 56.000 - 115.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Company car or car allowance

Medical, Dental and Vision benefits

401k matching

Employee Stock Purchase Plan

Bonuses/Commissions

Paid time off

Descripción de la vacante

Syneos Health is a leading life sciences services company seeking a regulatory affairs specialist focused on CMC to manage lifecycle submissions across US/CA/EU. The role involves regulatory strategy and cross-functional teamwork.

You will review CMC sections, interact with agencies, and collaborate with global teams to shape compliant submissions for assigned products. A bachelor’s degree in life sciences and about four years of pharma experience are preferred.

Formación

• Bachelor's degree in life sciences or related field.
• Typically 4 years of pharmaceutical industry experience or equivalent.
• Experience supporting Small Molecule programs preferred.

Responsabilidades

• Execute commercial Lifecycle Management strategy and submissions focused on US/CA/EU.
• Review CMC sections of regulatory submissions and agency interactions.
• Develop global regulatory CMC strategies in collaboration with Regulatory.
• Serve as primary regulatory CMC contact for assigned products/projects.

Conocimientos

Strong interpersonal skills

Regulatory guidelines proficiency

Problem-solving skills

Collaboration and communication

Planning and prioritization

cGMP knowledge

Educación

Bachelor's degree in life sciences

Descripción del empleo

Syneos Health is a leading life sciences services company seeking a regulatory affairs specialist focused on CMC to manage lifecycle submissions across US/CA/EU. The role involves regulatory strategy and cross-functional teamwork.

You will review CMC sections, interact with agencies, and collaborate with global teams to shape compliant submissions for assigned products. A bachelor’s degree in life sciences and about four years of pharma experience are preferred.