Regulatory Affairs Specialist III

HireTalent; Swiftwater (Monroe County); Remote; USD 60,000 - 80,000; Full time

Job summary

A leading staffing agency is seeking a Regulatory Affairs Specialist III for a 5-month project in Swiftwater, PA. The role involves authoring and reviewing regulatory documents for CMC submissions to the FDA. Candidates should have a scientific background, at least 3 years of experience in CMC writing, and knowledge of GMPs. Remote work is considered and there is a possibility of extension.

Qualifications

• Must have relevant experience in the CMC area including drug/biologics licensure.
• 3+ years of experience authoring CMC regulatory documents.
• Experience with FDA and international health authorities.

Responsibilities

• Author/review/approve CMC technical documents for regulatory submissions.
• Provide regulatory guidance for development projects.
• Utilize word processing software for documentation.

Skills

Technical writing experience

Analytical skills

Knowledge of GMP

Strong writing skills

Organizational skills

Tools

Microsoft Office

Documentum

Veeva Applications

Trackwise Applications

Job description

Job Title: Regulatory Affairs Specialist III

Job Location: Swiftwater, PA

Job Duration: 5 Months

REMOTE considered. Possibility of extension.

Job Description:

Responsibilities

• Candidate to author/review/approve CMC technical documents in the internal document system to support regulatory submissions (may include BLA, MAA, IND, supplements) to US FDA and international Health Authorities. Must have working knowledge of biologic/drug regulations (FDA, ICH, EU, etc) related to CMC.
• Provide regulatory guidance for development projects, post-approval CMC changes/variations. Must have working knowledge of GMPs. Must be well-organized, work with minimal management and meet aggressive timelines.
• Utilizes knowledge of word processing software, strong writing and analytical skills to document software capabilities and functionality.

Qualifications

• Relevant experience is required in the CMC area.
• Experience with drug/biologics licensure
• Prior regulatory experience
• Technical writing experience (CMC experience)
• Scientific background
• CMC/ Regulatory writing experience - 3 + years authoring CMC regulatory documents including Module 2 and Module 2.3
• Scientific background, vaccines preferred
• Microsoft Office (word, excel, powerpoint)
• Documentum/ Veeva Applications
• Trackwise Applications
• ICH Guidelines
• GMP experience
• Experience with drug/biologics licensure preferred