Senior Regulatory CMC Consultant: Small Molecule & RIM

Syneos Health/ inVentiv Health Commercial LLC; Boston (MA); On-site; USD 56,000 - 115,000; Full time

Benefits offered by this job

Health benefits

401k match

Employee Stock Purchase Plan

Bonus eligibility

PTO & Sick time

Job summary

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant for Small Molecule programs, with Veeva RIM experience. The role focuses on US/Canada/Europe submissions and cross-functional collaboration to develop global regulatory CMC strategies.

The candidate should have a bachelor’s degree in a life sciences field and 4 years in pharma, with preferred experience in Small Molecule programs. The company emphasizes a supportive culture, competitive benefits, and a strong focus on delivering

Qualifications

• Bachelor's degree in Life Sciences or related field.
• Typically requires 4 years of experience in the pharmaceutical industry or related field or equivalent.
• 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 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

Interpersonal skills

Regulatory guidelines

Problem-solving

Collaboration & communication

Planning & prioritization

cGMP/FDA/EMA/ICH knowledge

Education

Bachelor's degree in Life Sciences

Job description

Syneos Health is seeking a Manager/Senior Regulatory CMC Consultant for Small Molecule programs, with Veeva RIM experience. The role focuses on US/Canada/Europe submissions and cross-functional collaboration to develop global regulatory CMC strategies.

The candidate should have a bachelor’s degree in a life sciences field and 4 years in pharma, with preferred experience in Small Molecule programs. The company emphasizes a supportive culture, competitive benefits, and a strong focus on delivering