Manager, Regulatory Affairs-Chemistry Manufacturing & Controls (CMC)

AbbVie•North Chicago, IL

15h•Hybrid

About The Position

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 , Instagram , X and YouTube. The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Post Approval Change (PAC) is responsible for ensuring RA-CMC post approval change objectives are met by project managing marketed product variations including authoring and compilation of chemistry, manufacturing, and control (CMC) sections to ensure timely preparation of submission documents. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings. This position will work a hybrid work schedule from our Lake County, IL AbbVie headquarters.

Requirements

Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
6 years pharmaceutical or industry related experience.
3-5 years in quality systems or cross-functional project management.
Strong working knowledge of manufacturing unit operations or 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 with US and other international regulatory requirements for drug product dossiers

Nice To Haves

6 years pharmaceutical experience including 5 years in regulatory affairs or 5 years in Discovery, R&D, or Manufacturing
Prior experience in the preparation of CMC sections of regulatory dossiers including electronic submissions

Responsibilities

Independently manage, compile, and author CMC sections of marketed product variations.
Partner with RA CMC Project Leads to create and develop content plans, bundling strategies, and project timelines as needed.
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.
Drive team and management reviews with minimal intervention by project lead.
Provide coaching to more junior RA CMC colleagues during team and management reviews.
Ensure CMC expectations including CTD content, structural and formatting requirements are being met for assigned projects and for projects being managed by coached/mentored employees.
Independently provide tactical support to integrate technical issues with regulatory requirements and emerging standards.
Develop and utilize current best practices for use of regulatory business systems within the group.
Identification of systems issues and communication to management/key system SMEs.
Identify and communicate content gaps and risks for variation documents.
Coach, mentor, and develop junior staff.
Provide guidance on use of submission document templates.
Support annual reports and renewals (ad hoc baseline support)