Talentsearchpro ยท 1 month ago
CMC Writer with Pharmaceutical or Regulatory Writing Exp
Paramus_NJ
Full-time
Onsite
Mid LevelTalentsearchpro is seeking a Pharmaceutical CMC Writer who plays a crucial role in regulatory submissions by preparing technical documents related to drug development, manufacturing, and quality control. The role involves authoring various clinical documents and ensuring compliance with regulatory guidelines for submissions to agencies such as the FDA and EMA.
Responsibilities
Authors a range of clinical documents, including regulatory documents following defined templates, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Support the coordination and preparation of timely CMC file for AR/DSUR/RTQ submissions
Authoring and review of CMC submission components and documentation in CTD to support regulatory submissions for mainly EU (IMPD and MAA) and US-FDA (IND, BLA or NDA) submissions
Ensure completion of high-quality submissions, following regulatory guidelines and internal processes within timelines
Obtain information from other departments regarding regulatory submissions or documentation to support CMC submissions
Assess and communicate potential regulatory risks and propose mitigation strategies
Understands, interprets and advises teams on regulations, guidelines, procedures and policies relating to manufacture and control of medicinal products, to expedite the submission, and review and approval of applications
Identify, communicate and escalate potential CMC regulatory issues, as needed
Help establish regulatory CMC submission processes and procedures
Familiar with eCTD format submission files
Project management skill is plus
Regulatory Documentation: Author and review CMC sections of regulatory submissions, including IND, NDA, and MAA applications
Compliance & Guidelines: Ensure documents align with FDA, EMA, and ICH regulatory requirements
Collaboration: Work closely with scientists, regulatory affairs teams, and manufacturing experts to gather accurate data
Quality Assurance: Maintain consistency, clarity, and accuracy in technical writing
Process Improvement: Help establish regulatory CMC submission processes and procedures
Qualification
Required
Bachelor's or advanced degree in chemistry, pharmaceutical sciences, or a related field
Prior experience in pharmaceutical or regulatory writing
CMC (Chemistry, Manufacturing, and Controls) Writer experience
Preferred
Project management skill is plus
Company
Talentsearchpro
Talent Search Pro, we understand that making the right hire is a critical action that you have to take as an organization.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase