CMC Regulatory Technical Writer - REMOTE

Highly Competitive Salary
  1. Contract
  2. Consultant / Specialist, Publishing & Submissions, CMC
  3. United States
Pawnee City, USA
Posting date: 07 Sep 2023

This vacancy has now expired. Please see similar roles below...

Proclinical is seeking a remote CMC Regulatory Technical Writer for a global biopharmaceutical company.

Must be eligible to work in the US.

Job Responsibilities:

  • Author the CMC sections of regulatory documents (e.g., IND/IMPD, BLA/MAA, health authority questions, briefing documents) to support the timely submissions of investigational and marketing applications of primarily biologics
  • Contribute to global regulatory writing strategy for CMC content and drive CMC content requirements on assigned projects.
  • Interpret and summarize complex data in close collaboration with technical line SMEs
  • Develop timelines, prepare and manage the review and approval of submission ready documents.
  • Ensure submissions are complete and accurate, and comply with applicable regulatory requirements and expectations
  • Critical review of submission documents to ensure messaging is clear and consistent within and across documents
  • Well versed in formatting using Microsoft Word and authoring tools, and perform final copyediting checks of CMC documents

Skills and Requirements:

  • Experience in regulatory submissions, supporting the preparation of Module 3 components of a submission, related Quality/CMC documents and components, and regulatory briefing documents
  • Critical evaluation of analytical data with knowledge of fundamental principles of biochemistry, bioprocess, and/or pharmaceutical development
  • Good writing skills for technical content and scrupulous attention to detail
  • Excellent verbal communication skills for leading meetings and constructive remote interactions
  • Negotiate the delivery of approved technical documents in accordance with project timelines
  • Work well in team setting on a fast-paced business critical project
  • Able to work independently, strong ability to prioritize workload
  • Knowledge and experience using regulatory information management systems
  • Scientific background (B.S or M.S.) to understand pharmaceutical drug development concepts, CMC regulatory concepts, and create documentation based on these concepts
  • Comprehensive understanding of regulations and quality guidelines to enhance probability of regulatory success and compliance
  • Demonstrated excellence in project management

If you are having difficulty in applying or if you have any questions, please contact Jackie Cerchio at +(1) 267-846-2026 or

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.