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

Regulatory Jobs; Irvine (CA); Hybrid; USD 120,000 - 150,000; Full time

Job summary

AbbVie seeks a Senior Associate, RA CMC to lead post-approval variation activities, author and compile chemistry, manufacturing, and control sections, and ensure timely submission readiness. The role requires collaboration with RA CMC Project Leads and multiple global groups to maintain CTD content and format standards.

You will manage multiple CMC dossiers, drive project plans, and communicate risks and content gaps while supporting annual reports and renewals.

Qualifications

• BA/BS in Chemical and/or Biological Sciences required.
• 4 years pharmaceutical or industry experience; 1–2 years in quality systems or cross-functional project management.
• Preferred 5 years 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 management oversight. Update simple CMC documents independently.
• Partner with RA CMC Project Leads to create content plans, bundling strategies, 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. 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.

Skills

CTD structure

Communication skills

Regulatory knowledge

Cross-functional collaboration

Electronic document management

Project management

Attention to detail

Independence under pressure

US/international regulatory exposure

Education

BA/BS in Chemical and/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

. Follow @abbvie on

LinkedIn,

Facebook

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YouTube.

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