About this opportunity
Regulatory Jobs lists this Senior Associate, Regulatory Affairs - Chemistry, Manufacturing & Control (CMC) opportunity in north chicago, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
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
. Follow @abbvie on
LinkedIn,
,
,
X
and
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
#J-18808-Ljbffr
Worksite address
north chicago, IL, 60086, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.