60793 Automotive Service Advisor/Writer Rockland Chrysler Dodge Jeep Ram
Nanuet, NY30+ days ago
- Full-time
- Employee
Katalyst Healthcares and Life Sciences
- Hackensack
- 3 days ago
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Skills
- Accounts Receivableunmatched
- Biotech and Pharmaceuticalunmatched
- Chemistryunmatched
- Communication Skillsunmatched
- Cross-Functionalunmatched
- Delivery Managementunmatched
- Documentationunmatched
- Drug Developmentunmatched
- FDA (Food and Drug Administration)unmatched
- ICH Regulationsunmatched
- International Healthunmatched
- Interpret Regulationsunmatched
- Investigational New Drug (IND)unmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Analysisunmatched
- Manufacturing/Industrial Processesunmatched
- Marketing Authorization Application (MAA)unmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft Outlookunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Organizational Skillsunmatched
- Process Improvementunmatched
- Project/Program Managementunmatched
- Regulationsunmatched
- Regulatory Submissionsunmatched
- Technical Writingunmatched
- Time Managementunmatched
- Writing Skillsunmatched
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, andControls (CMC) deliverables across drug development programs.
- 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.
- 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
- 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
- Bachelor's or advanced degree in Chemistry, Pharmaceutical Sciences, or related field.
Numbers & Facts
| Location | Hackensack |
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