Project Manager, Regulatory CMC

Katalyst CRO; Paramus (NJ); Presencial; USD 120 000 - 170 000; Tempo integral

Resumo da oferta

Katalyst CRO is seeking an experienced CMC Writer/Project Manager to support regulatory submissions and deliver high-quality documentation for global health authorities. The role combines technical writing with project management to drive CMC deliverables across drug development programs.

Responsibilities include authoring and reviewing CTD/eCTD sections, managing timelines, coordinating AR/DSUR docs, ensuring FDA/EMA/ICH alignment, and collaborating with cross-functional teams to mitigate

Qualificações

• Minimum 5 years in pharmaceutical regulatory writing or CMC project management.
• Strong knowledge of manufacturing processes, analytical methods, specs, and validation.
• Familiar with global regulatory frameworks and eCTD submissions.
• Excellent technical writing, communication, and organizational skills.

Responsabilidades

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

Conhecimentos

Technical writing

Project management

Regulatory writing

GxP compliance

Formação académica

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Advanced degree in related field

Ferramentas

Veeva Vault

Smartsheet

Descrição da oferta de emprego

• 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.

• 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.