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

Company 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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Job Description

The Manager, Regulatory Affairs for Chemistry Manufacturing & Controls (CMC) Post Approval Change (PAC) 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. This position will also ensure proper communication with all key partners in the functional departments in support of regulatory filings.

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 ensurefile-abilityand acceptance of CMC sections.
• Manageassigned projectsto 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 developjuniorstaff.
• Provide guidance on use of submission document templates.
• Support annual reports and renewals (ad hoc baseline support)
• This position will work a hybrid work schedule from our Lake County, IL AbbVie headquarters.
  
  
  

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

Qualifications

• Minimum of a BA/BS Degree in Chemical, and/or, Biological Sciences/relevant discipline
• Required Experience: 6 years pharmaceutical or industry related experience. 3-5 years in quality systems or cross-functional project management. Preferred Experience: 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
• 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
  
  
  

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this postingbased on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemayultimatelypaymore orless than the posted range. This range may bemodifiedin thefuture.
• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.
• This job is eligible toparticipatein our short-term incentiveprograms.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission,incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremainsin the Company's sole andabsolutediscretion unless and until paidandmay bemodifiedat the Companys sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visithttps://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html