Regulatory Affairs Associate II - CMC Module 3 and Marketed Product Variations

Regulatory Affairs Associate II - CMC Module 3 and Marketed Product Variations
Location: Lake County, IL | Hybrid
Length of Assignment: 6 months initially
Pay Rate: $29-33/hr (medical benefits available at a cost)

Job Description

The Regulatory Affairs Associate II manages, authors, and compiles chemistry, manufacturing, and controls (CMC) sections for marketed product variations. The role partners with Regulatory Affairs CMC Project Leads and functional departments to develop CTD Module 3 content, establish project timelines, and prepare accurate, complete, and timely regulatory submission documents and responses.

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight. Ensure Common Technical Document (CTD) content, structural, and formatting requirements are met.
• Partner with Regulatory Affairs CMC Project Leads to develop Module 3 content and project timelines.
• Coordinate activities with functional departments in support of regulatory filings. Collaborate across functions to ensure CMC sections are suitable for filing and regulatory acceptance.
• Manage assigned projects to ensure the thoroughness, accuracy, and timely delivery of CMC dossiers and responses.
• Independently facilitate project team meetings and submission document review meetings.
• Manage multiple projects simultaneously and adjust priorities and strategies in response to changes in project scope, business objectives, and team feedback.
• Maintain awareness of current best practices and apply them when using regulatory business systems within the group.

Medical Device Responsibilities

• File necessary applications and manage interactions with government authorities for products requiring regulatory approval.
• Author and submit PMA supplements, including 30-Day Notices, Real-Time Reviews, 180-Day Supplements, and Annual Reports.
• Review and approve engineering study protocols and reports, validation study protocols and reports, and manufacturing changes for Class III implantable medical devices.
• Use experience and judgment to plan and accomplish goals, perform a variety of tasks, and exercise creativity and latitude. May lead and direct the work of others.

 Qualifications

• Knowledge of CMC expectations, including CTD Module 3 content, structural, and formatting requirements, and familiarity with US and international regulatory dossier requirements.
• Required experience: four years in the pharmaceutical industry and one to two years of cross-functional project management experience.
• Experience working with electronic document management systems and the ability to independently manage multiple projects and facilitate project and document review meetings.
• Minimum BA/BS degree in chemical sciences, biological sciences, or a relevant discipline.
• Superior oral and written communication skills and the ability to work cooperatively with global personnel at all levels.
• Strong attention to detail and accuracy; a collaborative approach and willingness to learn.
• Ability to adapt priorities and strategies to changes in project scope, business objectives, and team feedback.
• Preferred experience: five years in the pharmaceutical industry, including one to two years in Regulatory Affairs, R&D, or Manufacturing involving CTD Module 3.

Medical Device Experience

• Recent experience with Class III implantable medical devices and a proven record of authoring, submitting, and obtaining approval of Class III implantable PMA supplements.
• Knowledge of FDA PMA guidance documents and Code of Federal Regulations (CFR) requirements.
• An advanced degree and three to five years of direct experience in the field may be required.

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