Remote LATAM Regulatory Lead - Biologics & CMC

Syneos Health, Inc.; Washington (District of Columbia); Hybrid; USD 120,000 - 180,000; Full time

Job summary

Syneos Health in Washington, DC offers a remote opportunity for a Sr Regulatory Consultant focused on LATAM biologics and CTA programs. The role requires deep expertise in CMC, regulatory strategy and global submissions, with responsibility for leading cross‑functional teams to deliver compliant documentation on schedule.

You will execute lifecycle management for multiple products, review CMC sections with regulatory agencies, and develop global regulatory CMC strategies.

Qualifications

• Bachelor's degree in life sciences or related field.
• Typically requires 4 years of experience in pharmaceutical/regulatory affairs or related field.
• Preferred experience supporting Small Molecule programs.

Responsibilities

• Execute regulatory CMC submissions with focus on US/CA/EU.
• Review CMC sections and agency interactions.
• Develop global regulatory CMC strategies and submissions.
• Serve as primary regulatory CMC contact for assigned products.

Skills

Regulatory guidelines

Interpersonal skills

Planning & prioritization

Problem solving

Cross-functional collaboration

Education

Bachelor's degree in life sciences

Job description

Syneos Health in Washington, DC offers a remote opportunity for a Sr Regulatory Consultant focused on LATAM biologics and CTA programs. The role requires deep expertise in CMC, regulatory strategy and global submissions, with responsibility for leading cross‑functional teams to deliver compliant documentation on schedule.

You will execute lifecycle management for multiple products, review CMC sections with regulatory agencies, and develop global regulatory CMC strategies.