The Senior Associate, RA CMC 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. 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 ensure file-ability and acceptance of CMC sections.
- Manage assigned projects to 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
- 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
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 posting based 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 or less 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 paid and 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.
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