Remotely
project managementdocument managementregulatory affairscmcall otherctddossierelectronic submissions
Job Description
📋 Description
- Independently manage, compile, and author CMC sections of marketed product variations.
- Develop content plans, bundling strategies, and project timelines.
- Collaborate with cross-functional teams to ensure file-ability of CMC sections.
- Oversee projects to ensure thoroughness, accuracy, and timeliness of dossiers.
- Lead programs coordinating activities and resources across global post-approval changes.
- Ensure CTD content and formatting requirements are met; train on best practices.
🎯 Requirements
- BA/BS in Chemical and/or Biological Sciences (or relevant).
- 8 years pharmaceutical experience; prefer 10 with 5+ in RA or 5+ in Discovery/Manufacturing.
- Experience preparing CMC sections for regulatory dossiers and electronic submissions.
- Strong knowledge of manufacturing unit operations or CTD structure.
- Excellent oral and written communication; can work with global teams.
- Experience with electronic document management systems; ability to multitask.
🎁 Benefits
- Comprehensive benefits package (vacation, holidays, health insurance, 401(k)).
- Eligibility for long-term incentive programs.
- AbbVie is an equal opportunity employer; committed to diversity and inclusion.
