Labeling and Artwork Associate - Regulatory Affairs

Job Summary

The Labeling Associate supports the compliant and timely publication of product information, and ensures SPCs and PILs are accurately prepared and supported with complete, inspection-ready documentation. Working closely with Labeling Managers and other stakeholders, the role maintains labeling systems, workflow tools and mailboxes, and also supports regional labeling and artwork activities according to business needs.

Job Responsibilities

• Manage labelling publication: process approved SPCs and PILs for countries including UK and Ireland, monitor incoming requests, confirm that required documents and supporting information are complete. Support publication or associated labelling activities for markets where required.

• Prepare and publish approved documents accurately: complete administrative formatting , upload documents to the correct portal completing associated actions.

• Complete publication checks and follow-up: monitor portal notifications, quality-control comments, approvals, and publication status, and verify that the correct document and version available.

• Maintain compliance records and tracking: keep a complete, accurate, and inspection-ready audit trail; work in accordance with approved procedures, Job Aids, and portal guidance; meet established timelines.

• Identify, resolve issues: identify incomplete or inconsistent requests, obtain missing information, support independent quality checks and resolve portal issues.

• Provide operational and administrative support to Labeling Managers where appropriate.
• Support Labeling Manager by maintaining system management for labeling activities.
• Monitors system data integrity and quality checks.       

Here Is What You Need:

• Degree in life sciences, pharmacy, or a related field or equivalent professional experience

• Hands-on experience related to development, maintenance and commercialization activities

• Demonstrated ability to build strong, positive working relationships across multiple cultures and locations.

• Strong administrative, document-management or operational skills, with demonstrated accuracy when handling detailed information.

• Good written and verbal English and competence using Microsoft Office applications.

• Ability to work independently, while recognizing when guidance or escalation is required.
• Ability to work under tight timelines, apply sound judgment.

Bonus Points If You Have:

• Experience in a pharmaceutical, healthcare, regulatory or other highly regulated environment.

• Experience in labeling, artwork, regulatory affairs, publishing, document management, quality/compliance, controlled records or audit trails.

• Familiarity with SPCs, PILs, product information or international team working.
• Preferred experience with business analytics tools

• Proven technical aptitude and the ability to quickly learn new software, regulations, and standards.
• Ability to speak additional European language.

Work Location Assignment: Hybrid (some office presence is required)
 

Purpose 

Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.  

Digital Transformation Strategy

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

Equal Employment Opportunity 

We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.

DisAbility Confident

We are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.

Regulatory Affairs