Regulatory CMC Lead – Small Molecule & Veeva RIM

Syneos Health, Inc.; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Syneos Health, Inc. is seeking a Sr Regulatory CMC Consultant specialized in Small Molecule and Veeva RIM must-have expertise, for a global remit including the US, Canada and EMEA. The role emphasizes strong NA regulatory strategy, CMC knowledge, and collaboration across functional teams.

The incumbent will support regulatory planning, submissions, and compliance to advance development programs while ensuring alignment with global regulatory expectations and timelines.

Qualifications

• Bachelor's, Master's or PhD in life sciences (Biology, Chemistry, Pharmacy, Regulatory Affairs or related).
• Typically requires 8 years of pharma/biotech industry experience or equivalent.
• Experience with US/Canada regulatory submissions and CMC inputs is highly desirable.

Responsibilities

• Supports North America regulatory strategy under guidance of regional/global leads.
• Identifies regulatory requirements for submissions in North America.
• Manages preparation, submission and approval processes for NA regulatory applications.
• Provides technical regulatory input for key product development or registration documents.
• Ensures submissions comply with current regulations and guidance.

Skills

Regulatory affairs

Regulatory strategy

Regulatory submissions

Written communication

Verbal communication

Teamwork

Planning

Education

Biology / Chemistry / Pharmacy / Regulatory Affairs (Life sciences)

Job description

Syneos Health, Inc. is seeking a Sr Regulatory CMC Consultant specialized in Small Molecule and Veeva RIM must-have expertise, for a global remit including the US, Canada and EMEA. The role emphasizes strong NA regulatory strategy, CMC knowledge, and collaboration across functional teams.

The incumbent will support regulatory planning, submissions, and compliance to advance development programs while ensuring alignment with global regulatory expectations and timelines.