Global CMC Regulatory Affairs Specialist

Artech Information System LLC; Westborough (MA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading IT staffing company located in Westborough, Massachusetts is seeking a Regulatory Affairs professional. The role involves performing CMC work, supporting regulatory compliance, and coordinating with various departments. Candidates should possess a bachelor's degree and have at least 2 years of experience in Regulatory Affairs, along with excellent writing skills and fluency in CTD formats. This is a great opportunity to join a reputable organization focused on technical expertise in the industry.

Qualifications

• 2 years experience in a Regulatory Affairs related role.
• Authoring experience of CTD Module 2 & Module 3 sections.

Responsibilities

• Perform general Regulatory Affairs CMC work including dossier and document preparation.
• Support regulatory activities aligned with Health Authority requirements.
• Coordinate with cross-functional department personnel.

Skills

Excellent writing skills

Fluency in Common Technical Document (CTD)

Understanding of pharmaceutical manufacturing processes

Education

Bachelor's degree

Job description

A leading IT staffing company located in Westborough, Massachusetts is seeking a Regulatory Affairs professional. The role involves performing CMC work, supporting regulatory compliance, and coordinating with various departments. Candidates should possess a bachelor's degree and have at least 2 years of experience in Regulatory Affairs, along with excellent writing skills and fluency in CTD formats. This is a great opportunity to join a reputable organization focused on technical expertise in the industry.