Katalyst CRO

Regulatory Affairs Associate II

Katalyst CRO, Denver

Join to apply for the Regulatory Affairs Associate II role at Katalyst CRO

2 weeks ago Be among the first 25 applicants

Join to apply for the Regulatory Affairs Associate II role at Katalyst CRO

Get AI-powered advice on this job and more exclusive features.

Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Skills for running review meetings for submission documents. Understand CMC expectations including CTD content, structural and formatting requirements.
Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
Individuals are responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.

Job Description

Responsible for managing and compiling CMC sections of marketed product variations. Partner with RA CMC Project Leads and develop module 3 content and project timelines. Collaborate with diverse functional groups to ensure file-ability and acceptance of CMC sections.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses. Skills for running review meetings for submission documents. Understand CMC expectations including CTD content, structural and formatting requirements.
Maintains awareness of and utilizes current best practices for use of regulatory business systems within the group.
Individuals are responsible for managing the activities for marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will coordinate activities with all functional departments in support of regulatory filings.

Responsibilities:

Manage, compile, and author CMC sections of marketed product variations including CTD content, structural and formatting requirements are being met for assigned projects with minimal management oversight.
Manage assigned projects to ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.
Independently facilitate project team meetings.
Superior oral and written communication skills.
Ability to work cooperatively with all levels and types of global personnel required.
Experience working with electronic document management systems.
Ability to work independently. Manage multiple projects simultaneously.
Stay attuned to shifts in project scope, business objectives, and team feedback, adjusting priorities and strategies, as necessary.
Regulatory submission documentation creation background.
Detail/accuracy oriented, collaborative, and willing to learn.
Familiarity with US and other international regulatory requirements for dossiers.

Requirements:

Minimum of a BA/BS Degree in Chemical, and/or Biological Sciences/relevant discipline.
Required Experience: 4 years pharmaceutical. 1-2 years cross functional project management.
Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs, R&D, or Manufacturing (CTD Module 3).

Referrals increase your chances of interviewing at Katalyst CRO by 2x

Englewood, CO $88,500 - $110,000 2 days ago

Were unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.

#J-18808-Ljbffr