Senior Associate, Global Labelling Regulatory Affairs

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Overview

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since 1997, we apply our scientific expertise to create transformative medicines for genetic conditions. We develop medicines using genetics and molecular biology, with a diverse pipeline of commercial, clinical, and preclinical candidates that may be first-to-market or offer substantial benefits over existing options.

Senior Associate, Global Labelling Operations - Regulatory Affairs - London

Hybrid (2 days per week onsite in Central London)

Summary

This position is responsible for supporting the development, review, and management of US, EU, and international labelling artwork components for commercial products. Responsibilities include QC assessment and managing labelling changes for lifecycle products and supporting new labelling for new market applications. Support may include initiating artwork requests in the artwork management system, annotating labels, reviewing change management records, document control, QC documents, translations and verification, and tracking project milestones and status.

Responsibilities

• Initiate artwork requests and requirements for new or revised labelling components via the artwork management system (GLAMS)
• Manage implementation requirements worldwide
• Provide input to internal tracking systems/databases to control workflow and ensure labelling projects/submissions and implementation deadlines are met
• Assist with regulatory research supporting labelling activities
• Communicate with labelling managers to incorporate new regulatory requirements into labelling documents
• Work with Packaging Operations and Supply Chain to facilitate labelling for printed packaging components
• Monitor launch and/or release of revised labelling into production
• Ensure high quality labelling content, components, and supporting documentation
• Review final artworks and approve labelling for production; approve change requests for assigned projects; provide guidance to Supply Chain and QA on labelling implementation; support first launch into new markets

Review and prepare labelling documents

• Provide regulatory labelling support including QC of labelling documents, artwork QC, translations management, and project coordination
• Perform quality checks per local labelling requirements (EU, US, ROW)
• Manage electronic and physical labelling repositories
• Prepare communications for approved labelling to stakeholders
• Prepare drug listing and establishment registrations for the US
• Contribute to global labelling management and continuous improvement; review guidelines and regulations
• Ensure compliance with regulatory requirements and internal policies

Experience

Required Skills: 2-4 years in Regulatory Affairs with experience managing labelling submissions and artwork

• US and/or EU labelling experience; core labelling experience valued
• Experience with SPL/PLR or SmPC/PIL/QRD requirements
• Experience with global labelling processes and Company Core Data Sheets
• Experience with Veeva RIM and Artwork Management systems
• Experience in labelling review processes, standards, and industry best practice
• Experience implementing labelling components into manufacturing
• Strong organization and ability to manage complex projects and timelines
• Experience translating labelling; strong verbal and written communication; technical writing and presentation skills
• Ability to work independently and in a team; high attention to detail
• Thorough understanding of regulatory labelling requirements

Desired Skills: International labelling experience including Latin America, APAC, EEAM/MEA regions is desirable.

Education

Minimum qualification: degree, preferably in life sciences.

Location

Hybrid work requiring 2 days onsite per week in London.

Equal Opportunity

Equal Opportunity Employer/Veterans/Disabled. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.