Manager, Regulatory Affairs Strategic Global Labeling

24 Apr, 2022

Jobs

Manager, Regulatory Affairs Strategic Global Labeling

AbbVie
Irvine, CA/Remote (West Coast)

Job Description

About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on TwitterFacebookInstagramYouTube and LinkedIn.

The Manager, Regulatory Affairs Strategic Global Labeling, has overall accountability for the initial creation and relevant updates to labeling documents for their assigned development and marketed products. This includes global labeling (e.g. CCDS/CCSI) and US/EU labeling (e.g. package inserts) documents. The Manager also represents the organization at Senior level meetings (e.g., Executive Labeling Committee [ELC] meetings) regarding these labeling documents. Development of labeling for these products is based on study results, coordination of labeling reviews with interdisciplinary teams, preparation of labeling components for submission to regulatory agencies, and participation in labeling negotiations with these agencies. The position also includes subject matter expertise in labeling regulations (e.g., FDA labeling rules/guidance) and review of local labeling to ensure global consistency.
•Leads the Labeling Sub-team (LST) meetings based on knowledge of processes and regulations, ensures timely distribution of preparatory documents, identifies issues for discussion, prepares meeting minutes, and follows up on action items. Provides strategic labeling guidance to authors regarding appropriate content for labeling documents such as Company Core Data Sheet (CCDS), US Package Insert (USPI), Summary of Product Characteristics (SmPC), and Patient Labeling; Initiates Structured Product Labeling (SPL) requests.

•Assists in the development and review of local labeling in accordance with the CCDS.

•Interacts with business partners and global affiliates in providing strategic guidance as appropriate to ensure consistency and compliance of product labeling.
•Drives strategic labeling processes within teams based on knowledge of success with other products.  Makes recommendations to proactively optimize label language for assigned products.
•Maintains accurate files of labeling change history and associated documents, including annotations to data sources.
•Participates in other functional team meetings, reviews materials, and meets timelines (e.g. provides labeling-related review and input for safety documents).
•Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA.
•Demonstrates proficient and current labeling knowledge and educates team about new regulations impacting labeling. Invests substantial time to improve competency level in understanding and interpreting evolving FDA regulations and guidance.
•May indirectly manage work of other department members. Assists in training of new personnel and in the development of department processes/policies.

•Maintains knowledge of applicable corporate/company SOPs, guidelines, and working instructions related to product labeling.

Qualifications

•Required Education: Bachelor’s degree in Pharmacy, Biology, Chemistry, pharmacology or related subject
•Preferred Education: Advanced degree, e.g. PharmD•Required Experience: 2 years in Pharmaceutical or Regulatory required

•Preferred Experience: Drafting and reviewing product labeling, compiling supportive documentation, and demonstrates competence in marketed product labeling maintenance. Basic knowledge of global core data sheet guidance and US regulatory labeling requirements. Experience working with cross‑functional teams.

•Preferred Skills: Able to supervise projects and set daily priorities. Able to work in a complex and matrix environment. Strong problem solving with minimal guidance. Detail-oriented, well organized, and good planning skills. Excellent proofreading/editing skills are required. Excellent communication (verbal, writing, and presentation) skills necessary for interacting with regulatory project managers and multi-functional labeling review teams.
•Note: Higher education may compensate for years of experience

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
M
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.

Job posted: 2022-04-24