AbbVie is a global, research-driven biopharmaceutical company focused on developing innovative therapies for some of the world's most complex and critical conditions. Spun off from Abbott Laboratories in 2013, the company operates in key therapeutic areas including immunology, oncology, neuroscience, and eye care. With a workforce of approximately 50,000 employees worldwide, AbbVie is a major player in the pharmaceutical industry, consistently ranking among the top companies for research and development investment. In Spain, AbbVie maintains a robust presence with its commercial headquarters located in Madrid and a significant manufacturing facility in Tres Cantos. The company is recognized for its high-performance culture and commitment to diversity, making it an attractive destination for international professionals in medical affairs, clinical research, and specialized marketing. While many field-based roles require local language proficiency, the company's global nature provides opportunities for cross-border collaboration and career progression within the European market.

AbbVie was formed in 2013 following the separation from Abbott Laboratories. Since its inception, it has grown into a leading biopharmaceutical entity through significant R&D and strategic acquisitions, such as Allergan in 2020.

Regulatory Manager (Labeling Devices) - Temporary

AbbVie

Requirements

Qualifications

5-7 years in Regulatory, R&D or related area, 3 years in Regulatory preferred with experience in regulatory affairs device / drug product labeling or equivalent experience within the pharmaceutical medical device industry, European experience required.

A solid working knowledge of device labeling process is highly desirable. Candidates must be able to demonstrate strong project management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral). Strong team mindset.

Competent knowledge of and demonstrated ability to apply EU regulatory guidelines pertaining to device and drug product labeling. Must be able to work independently and be flexible with meetings on different time zones at both ends of the working day.

Benefits

Additional Information

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, visit https://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

Original Advert

Company Description

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. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Provide advice and counsel on EU MDR, device labeling and global translation process, communicating closely with impacted stakeholders.
Responsible for ensuring compliance with the SmPC & other labeling requirements for Summary of Product Characteristics (SmPC) and related patient insert and labeling (PI Annex I-III) for pharmaceutical products in Europe for assigned products.
Ensure alignment of overall key labeling statements and key messages across EU labeling documents for assigned products.
Ensure consistency of EU device and drug product labeling across assigned product lines and compliance with AbbVie policies and procedures.
Review/QC materials, author documents, meet submission timelines for assigned products including rapid response label/PI authoring and/or review.
In collaboration with other Global Labeling team members, analyze competitor labeling for products in same class to ensure AbbVie products have most competitive labeling. Maintain awareness of recent competitor approvals in class/region for assigned products.
Agree timelines for submission and implementation of drug product or device label changes through interface with RA Area product owners, Brand managers, supply chain, Global Label Management (GLM) and other functions as required.
Maintain active awareness of all relevant EU legislation and guidance relevant to EU devices / product information/ labeling and assess impact on AbbVie business and R&D programs, in collaboration with RPI.
Provide information for artwork briefs for EU, for device and drug product production artwork describe and communicate content and agreed timelines of changes to affiliates & GLM, provide master mock-ups/word documents to enable redlining in the EU. Present updates/forecasts to affiliates/LCC and other stakeholders at regular (bi-weekly) affiliate meetings for assigned products/devices.

Lead or support project work related to device labeling improvements or compliance or systems.
Support inspection readiness activities for assigned products.
Lead readability testing strategy for assigned products - including drafting bridge tests when needed and vendor management where required.
Take responsibility for device website maintenance for assigned products where applicable.
Manage the device labeling in the RIM system, including routing and approvals.
Support and provide guidance for other team members and products when required.
External representation for device labeling topics.