Remote Senior Regulatory CMC Consultant (Small Molecule)

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

Benefits offered by this job

Company car or car allowance

Health benefits (Medical, Dental and V

401k company match

Employee Stock Purchase Plan

Bonus based on company and individual

Flexible PTO and sick time

Job summary

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant focused on small molecule programs and Veeva RIM. Located remotely in the US, you will lead CMC lifecycle submissions, review regulatory CMC content for FDA/EMA/Health Canada, and partner with cross-functional teams to shape global strategies.

The role requires a BS/BA in life sciences and roughly 4 years pharma experience, with a preference for small molecule experience. Competitive salary and comprehensive benefits are offered.

Qualifications

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

Responsibilities

• Execute commercial Lifecycle Management (LCM) strategy and submissions with focus on US/CA/EU.
• Review CMC sections of regulatory submissions and agency interactions.
• Collaborate on global regulatory CMC strategies and submissions.
• May serve as primary regulatory CMC contact for assigned products/projects.

Skills

Interpersonal skills

Regulatory guidelines (FDA, EMA, ICH)

Problem-solving

Collaboration and communication

Planning and prioritization

cGMP knowledge

Education

Bachelor's degree in biology/chemistry/pharmacy/regulatory affairs

Job description

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant focused on small molecule programs and Veeva RIM. Located remotely in the US, you will lead CMC lifecycle submissions, review regulatory CMC content for FDA/EMA/Health Canada, and partner with cross-functional teams to shape global strategies.

The role requires a BS/BA in life sciences and roughly 4 years pharma experience, with a preference for small molecule experience. Competitive salary and comprehensive benefits are offered.