Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
Strong understanding of manufacturing processes and analytical methods.
Familiarity with global regulatory frameworks, especially eCTD submissions.
Excellent technical writing and communication skills.
Proficient in Microsoft Office Suite; knowledge of Veeva Vault or Smartsheet is a plus.
Responsibilities
Author and review CMC sections of regulatory submissions in CTD/eCTD format.
Manage timelines and deliverables for CMC workstreams.
Prepare and coordinate documentation for AR, DSUR, and regulatory responses.
Ensure compliance with FDA, EMA, and ICH guidelines.
Collaborate with cross-functional teams to gather technical information.
Identify regulatory risks and suggest mitigation strategies.
Support process improvements for CMC submission workflows.
Benefits
Collaborative work environment with cross-functional teams.
Opportunities for professional growth in regulatory processes.
Engagement with key stakeholders in drug development.
Access to training and resources in project management and regulatory writing.
Full Job Description
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.
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.
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
Education:
Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
