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Senior Manager, Regulatory Affairs Strategic Global Labeling
3 months ago
Company Description
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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onTwitter,Facebook,Instagram,YouTubeandLinkedIn.
Job Description
The Senior Manager Labeling RA, Strategic Global Labeling, develops and maintains US package inserts (USPI), European Union (EU) Summary of Product Characteristics (SmPC) and Company Core Data Sheets and coordinates review and approval of these documents with changing regulatory environments. Mentors and educates cross-functional team members concerning global consistency of labeling with minimal supervision for more complex material but generally functions independently. Develops and presents strategy to management and leads a team to successfully execute regulatory strategies within a therapeutic area. Works with several cross-functional teams and often at director level. Supports multiple therapeutic areas and effectively leads cross-functional groups in the completion of project tasks and sub-projects. May manage direct reports.
Responsibilities:
- Leads teams on labeling decisions based on knowledge of processes and regulations and precedence. Educates others regarding existing and new labeling regulations regarding CCDS, USPI, SmPC and Instructions for Use (IFUs).
- Reviews and assesses data to determine whether accurate and reproducible. Works with Labeling Subteams to assure new and revised is included as support documentation following internal approvals. Works with cross-functional teams and affiliates to address Health Authority requests globally in a timely manner and resolves labeling issues.
- Drives strategic labeling processes within Labeling Subteams based on knowledge of success with other products, proactively recommends optimal label language based on competitive knowledge and understanding of project data; prepares Target Product Labeling.
- Maintains accurate files of labeling change history and associated documents within Cosmos, including annotated labels back to source data. Works with Labeling Operations to ensure quality documents are internally maintained or submitted to FDA, ensures that direct reports are current with maintenance of their documents.
- Coaches and guides direct reports on their job tasks and for career growth. Participates at team meetings, reviews materials, authors documents and trains staff. Reviews work of direct reports as needed.
- Works with safety groups on safety issues and leads discussion on safety-related labeling changes. Makes decisions on assigned topics and those of direct reports based on experience with various products. Understands and supports regulatory implications on product profile. Works strategically with Global Regulatory Strategy and Safety to maintain an accurate safety profile for assigned products. Provides labeling input for Risk Management Plans, PSUR/PADER and safety documents.
- Provides labeling support to global affiliates regarding pre-approvals, submissions, renewals and competitive analysis.
- Presents process, strategy and product labeling at Senior level meetings including Regulatory Strategy Review (RSR), Regulatory Strategy Team (RST), Global Regulatory Product Team (GRPT), Labeling Review and Strategy Team (LRST), Executive Leadership Committee (ELC) and joint company meetings for third party agreements, all under the direction of the Director, Strategic Global Labeling.
Leveling of the role is flexible based on candidates experience.
Qualifications- Required Education: Bachelors degree in Pharmacy, Biology, Chemistry pharmacology or related Subject. Preferred Education: Bachelors degree, certifications a plus
- Required Experience: 7 years in pharmaceutical, regulatory, R&D or related area, relevant experience in labeling or area that could link to labeling
- Ability to supervise projects and set daily priorities autonomously, able to work in a complex and matrixed environment
- Preferred Experience: 4 years in pharmaceutical, clinical or regulatory preferred
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 posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in 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 to participate in our short-term incentiveprograms.
This job is eligible to participate in our long-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 employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.
AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.
