Remote Senior Regulatory CMC Consultant - Small Molecule

Syneos Health, Inc.; Canada; Teletrabalho; CAD 56 000 - 115 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Health benefits

Company car or car allowance

Paid time off

Resumo da oferta

Syneos Health, Inc. is seeking a Mgr/Sr Regulatory CMC Consultant (Small Molecule & Veeva RIM Must Have) to lead regulatory CMC submissions across US, Canada and EU. This remote role collaborates with development teams to shape global strategies and ensure compliant submissions.

You will review CMC sections, engage with regulatory agencies, and contribute to cross-functional packages while leveraging experience in small molecule programs and regulatory guidelines to deliver timely outcomes.

Qualificações

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs or related field.
• Typically requires 4 years of pharma industry experience or equivalent.
• Preferred experience supporting Small Molecule programs.

Responsabilidades

• Execute regulatory CMC submissions with focus on US/CA/EU.
• Review CMC sections of submissions and interactions with agencies.
• Develop global regulatory CMC strategies in collaboration with other functions.
• Possibly serve as primary regulatory CMC contact for assigned products/projects.

Conhecimentos

Interpersonal skills

Regulatory guidelines

Problem solving

Communication

Planning

cGMP knowledge

Formação académica

Bachelor's degree in life sciences

Descrição da oferta de emprego

Syneos Health, Inc. is seeking a Mgr/Sr Regulatory CMC Consultant (Small Molecule & Veeva RIM Must Have) to lead regulatory CMC submissions across US, Canada and EU. This remote role collaborates with development teams to shape global strategies and ensure compliant submissions.

You will review CMC sections, engage with regulatory agencies, and contribute to cross-functional packages while leveraging experience in small molecule programs and regulatory guidelines to deliver timely outcomes.