CMC Regulatory Technical Writer

SUMMARY:

• Seeking an experienced CMC Writer / Project Manager to support regulatory submissions and ensure timely, high-quality documentation for global health authorities.
• This role combines technical writing expertise with project management skills to drive Chemistry, Manufacturing, and Controls (CMC) deliverables across drug development programs.

JOB DESCRIPTION:

• 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

KEY RESPONSIBILITIES:

• Author and review CMC sections of regulatory submissions (IND, NDA, BLA, MAA, IMPD) in CTD/eCTD format.
• Manage timelines and deliverables for CMC workstreams, ensuring alignment with project goals.
• Prepare and coordinate CMC documentation for AR, DSUR, and responses to regulatory authority questions.
• Ensure compliance with FDA, EMA, and ICH guidelines and internal processes.
• Collaborate with cross-functional teams to gather accurate technical information.
• Identify and communicate potential regulatory risks; propose mitigation strategies.
• Support process improvement initiatives for CMC submission workflows.

QUALIFICATIONS:

• Education: Bachelor’s or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
• Experience: Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
• Strong knowledge of manufacturing processes, analytical methods, specifications, and validation activities.
• Familiarity with global regulatory frameworks and eCTD submissions.
• Excellent technical writing, communication, and organizational skills.
• Proficiency in Microsoft Office Suite (Word, Excel, Outlook 365, PowerPoint).
• Veeva Vault, Smartsheet are plus

PREFERRED SKILLS:

• Experience with any of IND/NDA/BLA submissions and EU MAA/IMPD filings.
• Ability to interpret and apply regulatory guidelines effectively.
• Strong project management and stakeholder communication skills.

Pay: $45.00 - $50.00 per hour

Work Location: In person

Salary : $45 - $50