Regulatory Affairs CMC

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

Artech is the 10th Largest IT Staffing Company in the US, according to Staffing Industry Analysts' 2012 annual report. Artech provides technical expertise to fill gaps in clients' immediate skill-sets availability, deliver emerging technology skill-sets, refresh existing skill base, allow for flexibility in project planning and execution phases, and provide budgeting/financial flexibility by offering contingent labor as a variable cost.

Job Description

Job Description:

• Perform general Regulatory Affairs Chemistry Manufacturing and Controls (CMC) work including dossier and document preparation for various commercial and/or development product applications.
• Support regulatory activities for the strategies aligned with Health Authority requirements from a global perspective, and supporting the on-time submission of regulatory submissions.
• Additional duties may include regulatory compliance administrative support
• Coordination with cross functional department personnel from regulatory, quality, and manufacturing sites.
• Provide support for other CMC projects and tasks as needed.

Qualifications

Basic Qualification:

• Bachelor's degree with 2 years experience in a Regulatory Affairs related role
• Fluency in the understanding and format of the Common Technical Document (CTD)
• Authoring experience of CTD Module 2 & Module 3 sections
• Excellent writing skills
• Basic understanding of pharmaceutical manufacturing processes