Senior Manager, Regulatory Affairs

Omaha, NE - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Responsibilities:

The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings.
This role requires a strong understanding of the drug development process pharmaceutical technology and regulatory requirements while collaborating with cross-functional teams to meet technical writing and submission management objectives.
Support the CMC regulatory writing for high-quality and compliant regulatory CMC documentation (e.g. INDs CTAs MAAs NDAs and their amendments/variations/supplements as applicable) within defined timelines.
Support Regulatory CMC submission management.
Support determination of regulatory and scientific/technical requirements for CMC submissions.
Maintain knowledge of CMC regulatory requirements for drug development through post-approval and annual updated.

Requirements:

BS in Chemistry Pharmaceutical Sciences Regulatory Affairs or other relevant fields.
3 - 5 years of experience in authoring CMC sections of regulatory filings.
Demonstrated competency in clear and concise technical writing ability.
Understanding of CMC manufacturing documentation requirements.
Experience with regulatory submissions and requirements including eCTD documents required for INDs NDAs and MAAs supplements and briefing documents.
Ability to read and interpret regulations and guidance.
Excellent team interaction skills and ability to work successfully in a cross-functional team.
Ability to work in a dynamic environment with a high degree of flexibility.
Independent management of projects.
Well organized flexible and able to communicate effectively within CMC functions and Regulatory affairs both spoken and in writing.

Responsibilities: The Senior Manager Regulatory CMC Technical Writing and Submission Management role will be responsible for supporting the authoring compiling and management of CMC sections for global regulatory filings. This role requires a strong understanding of the drug development process pha...