Regulatory CMC Lead – Small Molecule & RIM Expert

1195 Syneos Health US, Inc.; Massachusetts; Hybrid; USD 56,000 - 115,000; Full time

Benefits offered by this job

Health benefits

401k

Employee Stock Purchase Plan

Commissions/Bonus

Flexible PTO

Job summary

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant specializing in Small Molecule and Veeva RIM to drive regulatory submissions in US, Canada, and EU.

The role requires strong knowledge of FDA/EMA guidelines, a Bachelor’s degree in life sciences, and at least 4 years building global CMC strategies. You will work with cross-functional teams to ensure compliant, timely submissions and effective regulatory communication.

Qualifications

• Bachelor’s degree in Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or medical devices.
• Typically requires 4 years of pharmaceutical industry experience or equivalent combination.
• 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 knowledge

Cross-functional collaboration

Regulatory submissions

Strong communication

Education

Bachelor's degree in Life Sciences

Job description

Syneos Health is seeking a Mgr/Sr Regulatory CMC Consultant specializing in Small Molecule and Veeva RIM to drive regulatory submissions in US, Canada, and EU.

The role requires strong knowledge of FDA/EMA guidelines, a Bachelor’s degree in life sciences, and at least 4 years building global CMC strategies. You will work with cross-functional teams to ensure compliant, timely submissions and effective regulatory communication.