Job Description
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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job Description
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.
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)
- 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 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
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this postingbased on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more orless than the posted range. This range may be modified in the future.
We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission,incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company’s sole and absolute discretion unless and until paidand may be modified at the Company’s sole and absolute discretion, consistent with applicable 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, visit https://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
