Senior Regulatory CMC Consultant – Small Molecule (Remote)

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

Benefits offered by this job

Company car

Health benefits

401k match

Employee stock purchase plan

Bonus eligibility

Flexible PTO & sick time

Job summary

Syneos Health, Inc. is seeking aMgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have. This remote-based role covers US/Canada/EU submissions and requires strong regulatory CMC expertise for drugs, biologics, or devices.

The position emphasizes cross-functional teamwork, process-driven submission strategies, and collaboration with regulatory agencies. Candidates should have a life sciences degree and several years of industry experience in CMC regulatory affairs.

Qualifications

• Bachelor's degree in life sciences; Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs/Devices recommended.
• Typically requires 4 years of pharma industry experience or equivalent.
• Experience supporting Small Molecule programs preferred.

Responsibilities

• Execute regulatory CMC submissions with focus on US/Canada/EU.
• Review CMC sections of regulatory submissions and interactions with agencies.
• Develop global regulatory CMC strategies with cross-functional teams.
• May serve as the primary regulatory CMC contact for assigned products/projects.

Skills

Regulatory knowledge

Interpersonal skills

FDA/EMA/ICH knowledge

Planning & prioritization

Education

Bachelor's degree in life sciences

Job description

Syneos Health, Inc. is seeking aMgr/Sr Regulatory CMC Consultant - Small Molecule & Veeva RIM Must Have. This remote-based role covers US/Canada/EU submissions and requires strong regulatory CMC expertise for drugs, biologics, or devices.

The position emphasizes cross-functional teamwork, process-driven submission strategies, and collaboration with regulatory agencies. Candidates should have a life sciences degree and several years of industry experience in CMC regulatory affairs.