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.
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The Senior Regulatory Associate, Regulatory Affairs, Strategic Global Labeling- Operations assists with creation and maintenance in prescription drug, over the counter (OTC), cosmetic and/or device product labeling in Regulatory Information Management and global labeling systems to meet regulatory requirements. Actively contributes to the development and implementation of product labeling for marketed products and for monitoring the labeling activity in the RIM system for products and ensuring the completeness and accuracy of RIM data. Works with Strategic Global Labeling and submission teams to provide appropriate guidance for managing the lifecycle of product submissions, applications and authorizations in the RIM system, as described in functional area procedures; and is responsible for managing product drug listings (US SPL and CA SPM) and products in development.
Serves as regulatory labeling operations representative on relevant project teams. Independently performs job tasks and interfaces with cross-functional groups as needed.
Responsibilities
- ✓Assists with creating ores and maintaining product labeling in the RIM global labeling systems including redlined, proposed and cumulative labeling documents.
- ✓Represents Strategic Global Labeling- Operations in cross-functional meetings regarding business processes and implementation of RIMGLS system updates.
- ✓Demonstrates ability to use electronic-based applications and systems, such as MSOffice, DocX Tool, Label/Regulatory Intelligence platforms, eDMS, data analytics tool(s), etc., for completing daily tasks
- ✓Responsible (with manager’s oversight as needed) for educating internal customers on Regulatory information issues including commercial, public affairs, clinical development, legal, quality and others who contribute to RIM.
- ✓Demonstrates ability to apply knowledge in a regulated environment, and functions independently in decision making for routine issues, while completing labeling inquiries from cross-functional areas, often under tight timelines.
- ✓Provides SME support on labeling systems and processes. Troubleshoots errors and system performance issues related to the RIM systemGLS. Coordinates with Program Support and IT to identify and resolve GLS RIMsystem issues.
- ✓Consistently exercises good judgment in the application of policies and regulations. Works well with other individuals and departments in solving problems.
- ✓Prepares routine communications for functional area and senior leadership as requested, including core labeling information dissemination.
- ✓Executes business processes for product information management within RIM system, labeling document reviews (format and content) and for US drug listings and CA XML-PM tasks.
- ✓May informally manage the work of other department members. Assists in training of new personnel and in the development of department processes/policies.
Required
- ✓Education: Bachelor’s degree in (pharmacy, biology, chemistry, medical technology pharmacology) related life sciences, or Associate’s degree and 8 years related experience
- ✓Required Experience: 3+ years in regulatory affairs, R&D or related area.
- ✓Experience working in a complex global matrix environment with diverse team members. Strong communication skills, both oral and written, and strong attention to detail, with problem-solving skills
- ✓Preferred Experience: Experience working with electronic regulatory submissions, software tools, and data standards, prior experience in a regulatory affairs strategy role preferred.
- ✓Note: Higher education may compensate for years of experience
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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