Manager, Regulatory Affairs, Strategic Global Labeling (Office-based)

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 onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Strategic Global Labeling Manager in Regulatory Affairs is responsible for developing and delivering patient-centered global product labeling for the safe and effective use of AbbVie products. The key responsibilities include leading cross-functional teams to develop comprehensive label strategies and create accurate labeling for development and marketed products, ensuring compliance with company procedures and applicable regulations.

Responsibilities

• Develop and maintain target labeling and prescribing information, including company core data sheets, and US and EU labeling documents, through the product lifecycle. Make recommendations to proactively optimize labeling language, including effective use of target labeling as applicable, for assigned products. Product portfolio will include pharma, OTC, and/or device or combination products.
• Lead cross-functional labeling teams to develop comprehensive label strategies and create accurate labeling for development and marketed products by understanding supporting data and leveraging knowledge of labeling regulations, precedent, and company processes to guide strategy and content development.
• Lead cross-functional team discussion of safety-related labeling changes and process the labeling in accordance with internal labeling procedures.
• Maintain documentation within regulatory information management system.
• Co-lead cross-functional labeling and regulatory strategy team (with guidance).
• Provide guidance to affiliates on labeling proposals and responses to health authorities.
• Present/communicate labeling strategies and decisions to senior and executive leadership.
• Represent the department on cross-functional regulatory and safety teams; contribute to and review regulatory and safety documents for labeling content.
• Contribute to or lead departmental or cross-functional process improvement initiatives.
  
  
  

Significant Work Activities:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required

Qualifications

• Required Education: Bachelors degree in Pharmacy, Biology, Chemistry, Pharmacology or related subject.Preferred Education: Advanced degree. Certifications a plus
• Required Experience: 6 years in Pharmaceutical, regulatory, R&D or industry related area. Experience in labeling or area that could link to labeling.Preferred Experience: 3 years in pharmaceutical or regulatory preferred. Minimum 3 years experience in clinical or pharmaceutical preferred
• Strong communication, collaboration, time management, and problem-solving skills.
• Proactive, able to manage multiple projects simultaneously, and set daily priorities. Able to work in a complex and matrixed environment.
• Ability to lead live or virtual meetings and document team decisions.
• Note: Higher education may compensate for years of experience
• This role will work a hybrid work schedule (3 days in office) from the Irvine, Californiaheadquarters.
  
  
  

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 thetimeof 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 anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's soleandabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable 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, visithttps://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