Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC)

Regulatory Jobs; North Chicago (IL); Hybrid; USD 90,000 - 120,000; Full time

Job summary

AbbVie is seeking a Senior Associate, RA CMC to manage and author CMC sections for marketed product variations. You will collaborate with RA CMC project leads to align content plans, bundling strategies, and timelines.

The role requires strong communication, regulatory knowledge, and experience with document management systems. Minimum 4 years in pharma or related industry with 1–2 years in quality systems or cross-functional project management.

Qualifications

• Bachelor-level degree in chemical, biological sciences or related discipline is required.
• 4 years of pharmaceutical or industry experience; 1–2 years in quality systems or cross-functional project management.
• Preferred: 5 years of pharmaceutical experience including 1–2 years in regulatory affairs or 1–2 years in Discovery, R&D, or Manufacturing.

Responsibilities

• Manage, compile, and author CMC sections of marketed product variations with minimal oversight.
• Coordinate content plans, bundling strategies, and project timelines with RA CMC leads.
• Collaborate with cross-functional groups to ensure CMC dossier readiness and acceptability.
• Lead team reviews of submission documents and ensure CTD content compliance.
• Provide guidance on submission document templates and lifecycle processes.
• Support annual reports and renewals as needed.

Skills

CTD structure

Communication skills

Regulatory knowledge

Document management

Project management

Detail oriented

Independent work

Team collaboration

US/intl regs

Education

BA/BS in Chemical or Biological Sciences

Job description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at

www.abbvie.com

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LinkedIn,

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The Senior Associate, RA CMC is responsible for ensuringRA-CMC post approval changeobjectivesare metbyproject managing marketed product variations including authoring and compilation of chemistry,manufacturing,and control (CMC) sections to ensure timely preparation of submission documents. The Senior Associate will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

Responsibilities:

• Manage, compile, and author CMC sections of marketed product variations with minimal management oversight.Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines.
• Collaborate with diverse functional groups to ensurefile-abilityand acceptance of CMC sections.
• Manageassigned projectsto ensure thoroughness, accuracy, and timeliness of CMC dossiers and responses.Independently run team review and management reviews of submission documents.
• Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects.
• Provide input into and utilize current best practices for use of regulatory business systems within the group.
• Timely communication of systems issues to management.
• Communicate content gaps and risks for variation documents identified by RA CMC Project Leads.
• Provide guidance on use of submission document templates.

Support annual reports and renewals (ad hoc baseline support)

This role works a hybrid work schedule (3 days in office & 2 days remotely) from the Lake County, IL; Waltham, MA or Irvine, CA AbbVie headquarters.

Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline

Required Experience: 4 years pharmaceutical or industry related experience. 1-2 years in quality systems or cross functional project management

Preferred Experience: 5 years pharmaceutical experience including 1-2 years in regulatory affairs or 1-2 years in Discovery, R&D, or Manufacturing

Key Qualifications:

• Strong working knowledge of manufacturing unit operationsor CTD structure
• 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 under pressure and manage multiple projects simultaneously
• Detail/accuracy oriented
• Collaborative and willing to learn
• Familiarity withUS andother international regulatory requirements for drug product dossiers