Katalyst CRO
Regulatory Affairs AssociateII(CMC)
Katalyst CRO, Jersey City, New Jersey, United States, 07390
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Regulatory Affairs Associate II (CMC)
role at
Katalyst CRO .
The individual is responsible for managing activities for marketed product variations, including authoring and compiling chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position coordinates activities with all functional departments in support of regulatory filings.
Responsibilities
Managing and compiling CMC sections of marketed product variations.
Partnering with RA CMC Project Leads to develop Module 3 content and project timelines.
Collaborating with diverse functional groups to ensure file‑ability and acceptance of CMC sections.
Managing assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Running review meetings for submission documents.
Understanding CMC expectations including CTD content, structural, and formatting requirements.
Maintaining awareness of and utilizing current best practices for use of regulatory business systems within the group.
Qualifications
Bachelor’s degree in Science; 4 years pharmaceutical experience; 1‑2 years cross‑functional project management.
Minimum of a BA/BS degree in Chemical, Biological Sciences, or relevant discipline with 5 years pharmaceutical experience, including 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Background in regulatory submission documentation creation.
Ability to compile and author CMC sections for marketed product variations, ensuring CTD content, structural, and formatting requirements are met with minimal oversight.
Excellent oral and written communication skills.
Ability to work cooperatively with all levels and types of global personnel.
Experience with electronic document management systems.
Self‑management and ability to handle multiple projects simultaneously.
Adjusting priorities and strategies as needed in response to changes in project scope, business objectives, and team feedback.
Detail‑ and accuracy‑oriented, collaborative, and eager to learn.
Familiarity with US and international regulatory requirements for dossiers.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Legal
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Regulatory Affairs Associate II (CMC)
role at
Katalyst CRO .
The individual is responsible for managing activities for marketed product variations, including authoring and compiling chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position coordinates activities with all functional departments in support of regulatory filings.
Responsibilities
Managing and compiling CMC sections of marketed product variations.
Partnering with RA CMC Project Leads to develop Module 3 content and project timelines.
Collaborating with diverse functional groups to ensure file‑ability and acceptance of CMC sections.
Managing assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Running review meetings for submission documents.
Understanding CMC expectations including CTD content, structural, and formatting requirements.
Maintaining awareness of and utilizing current best practices for use of regulatory business systems within the group.
Qualifications
Bachelor’s degree in Science; 4 years pharmaceutical experience; 1‑2 years cross‑functional project management.
Minimum of a BA/BS degree in Chemical, Biological Sciences, or relevant discipline with 5 years pharmaceutical experience, including 1‑2 years in regulatory affairs, R&D, or manufacturing (CTD Module 3).
Background in regulatory submission documentation creation.
Ability to compile and author CMC sections for marketed product variations, ensuring CTD content, structural, and formatting requirements are met with minimal oversight.
Excellent oral and written communication skills.
Ability to work cooperatively with all levels and types of global personnel.
Experience with electronic document management systems.
Self‑management and ability to handle multiple projects simultaneously.
Adjusting priorities and strategies as needed in response to changes in project scope, business objectives, and team feedback.
Detail‑ and accuracy‑oriented, collaborative, and eager to learn.
Familiarity with US and international regulatory requirements for dossiers.
Seniority Level Mid‑Senior level
Employment Type Full‑time
Job Function Legal
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