Senior Regulatory CMC Consultant - Small Molecule Focus

Syneos Health, Inc.; United States; On-site; USD 56,000 - 115,000; Full time

Job summary

Syneos Health, Inc. is seeking a Manager/Senior Regulatory CMC Consultant specializing in Small Molecule with Veeva RIM experience to lead regulatory CMC submissions in the US, Canada, and EU. You will review CMC sections, develop global CMC strategies, and collaborate across functions to drive timely approvals and ensure compliance. This role emphasizes cross-functional teamwork and strategic regulatory leadership.

Qualifications

• Bachelor's degree in biology, chemistry, pharmacy, regulatory affairs for drugs, biologics or medical devices, or another related life-science field.
• Typically requires 4 years of experience in the pharmaceutical industry or related field, or the equivalent combination of education and experience.
• Preferred experience supporting Small Molecule programs.

Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with a focus on US/CA/EU.
• Reviews CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies.
• Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions.
• Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and projects.

Skills

Regulatory Affairs

FDA regulations

EMA guidelines

ICH guidelines

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Tools

Veeva RIM

Job description

Syneos Health, Inc. is seeking a Manager/Senior Regulatory CMC Consultant specializing in Small Molecule with Veeva RIM experience to lead regulatory CMC submissions in the US, Canada, and EU. You will review CMC sections, develop global CMC strategies, and collaborate across functions to drive timely approvals and ensure compliance. This role emphasizes cross-functional teamwork and strategic regulatory leadership.