Katalyst CRO
Senior Manager, Regulatory Affairs
Katalyst CRO, Charlotte, North Carolina, United States, 28245
Overview
Be among the first 25 applicants
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.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Get notified about new Senior Manager Regulatory Affairs jobs in
Charlotte, NC .
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
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.
Seniority level
Associate
Employment type
Contract
Job function
Legal
Industries
Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Katalyst CRO by 2x
Get notified about new Senior Manager Regulatory Affairs jobs in
Charlotte, NC .
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr