Associate Director, RA-CMC PAC DM
AbbVie
August 20, 2026
Remote friendly (North Chicago, IL)
United States
$141,500 - $268,500 USD yearly
Other
Responsibilities:
- Ensure RA-CMC post-approval change objectives are met by project managing marketed product variations, including authoring and compiling CMC (chemistry, manufacturing, and control) sections for timely submission documents.
- Communicate with key functional partners to support regulatory filings.
- Manage, coach, mentor, and develop junior staff, including onboarding.
- Independently manage, compile, and author CMC sections; update moderately complex CMC documents.
- Develop initial content plans, bundling strategies, and project timelines; partner with RA CMC Project Leads.
- Collaborate with cross-functional groups to ensure CMC section file-ability and acceptance.
- Manage projects for thoroughness, accuracy, and timeliness of CMC dossiers and responses; drive team/management reviews with minimal lead intervention and coach junior colleagues.
- Lead business-critical programs via coordination of activities and global resource management for multiple post-approval changes.
- Ensure CTD content, structural, and formatting requirements are met consistently; train on best practices for regulatory business systems.
- Provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
- Identify and communicate content gaps and risks; guide usage teams and update submission templates.
- Support annual reports and renewals (ad hoc baseline support).
Qualifications:
- BA/BS in Chemical and/or Biological Sciences (or relevant discipline).
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs OR 5+ years in Discovery/R&D OR Manufacturing; 2+ years supervising employees.
- Prior experience preparing CMC sections for regulatory dossiers (including electronic submissions).
- Strong knowledge of manufacturing unit operations or CTD structure.
- Superior oral/written communication; cooperative with global teams.
- Experience with electronic document management systems.
- Ability to work independently under pressure and manage multiple projects.
- Detail/accuracy oriented; collaborative and willing to learn.
- Familiarity with US and other international regulatory requirements for drug product dossiers.
- Ensure RA-CMC post-approval change objectives are met by project managing marketed product variations, including authoring and compiling CMC (chemistry, manufacturing, and control) sections for timely submission documents.
- Communicate with key functional partners to support regulatory filings.
- Manage, coach, mentor, and develop junior staff, including onboarding.
- Independently manage, compile, and author CMC sections; update moderately complex CMC documents.
- Develop initial content plans, bundling strategies, and project timelines; partner with RA CMC Project Leads.
- Collaborate with cross-functional groups to ensure CMC section file-ability and acceptance.
- Manage projects for thoroughness, accuracy, and timeliness of CMC dossiers and responses; drive team/management reviews with minimal lead intervention and coach junior colleagues.
- Lead business-critical programs via coordination of activities and global resource management for multiple post-approval changes.
- Ensure CTD content, structural, and formatting requirements are met consistently; train on best practices for regulatory business systems.
- Provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
- Identify and communicate content gaps and risks; guide usage teams and update submission templates.
- Support annual reports and renewals (ad hoc baseline support).
Qualifications:
- BA/BS in Chemical and/or Biological Sciences (or relevant discipline).
- Required: 8 years pharmaceutical experience.
- Preferred: 10 years pharmaceutical experience including 5+ years in regulatory affairs OR 5+ years in Discovery/R&D OR Manufacturing; 2+ years supervising employees.
- Prior experience preparing CMC sections for regulatory dossiers (including electronic submissions).
- Strong knowledge of manufacturing unit operations or CTD structure.
- Superior oral/written communication; cooperative with global teams.
- Experience with electronic document management systems.
- Ability to work independently under pressure and manage multiple projects.
- Detail/accuracy oriented; collaborative and willing to learn.
- Familiarity with US and other international regulatory requirements for drug product dossiers.