Informacje o stanowisku

We are currently seeking a Manager, RA Global Labeling Product Leader to join a globally recognized pharmaceutical company. This individual will be responsible for the development and maintenance of primary and derived labeling documents across a various of therapeutic areas. The role also involves contributing to the global labeling strategy, collaborating with cross-functional teams, and ensuring the scientific integrity and regulatory compliance of labeling materials.

What we expect

education:

• University degree (Bachelor’s) in Life Sciences; Advanced degree (MS, PhD, PharmD) preferred

experience:

• a minimum of 4 years of experience in the pharmaceutical industry or with regulatory authorities
• at least 3 years of experience in regulatory affairs, with a specific focus on product labeling and labeling regulations
• proven experience working in matrix teams and leading collaborative, customer-oriented initiatives
• strong proficiency in technical, scientific, or regulatory writing
• expertise in document management systems

key skills:

• deep understanding of labeling regulations globally (EU, US, CIOMS, etc.)
• knowledge of drug development processes and regulatory requirements
• strong communication skills, both written and verbal
• ability to manage multiple projects and interact with global teams in a matrix environment
• collaborative, customer-focused mindset with the ability to influence others

Employment agency entry number 47

this job offer is intended for people over 18 years of age

What we offer

• employment contract for 12 months
• hybrid work model (office in Warsaw)
• benefits package: medical care, multisport card, life insurance
• work in an international environment

Your tasks

• develop and maintain primary and derived labeling documents for assigned products
• collaborate with Subject Matter Experts (SMEs) to revise, review, and finalize labeling documents
• lead and support Labeling Working Group (LWG) and Labeling Committee (LC) processes to ensure alignment with global regulatory requirements
• work closely with global regulatory affairs (GRA), global labeling operations (GLO), and third-party companies to manage labeling issues and ensure consistency
• contribute to continuous improvement initiatives within the Global Labeling process
• ensure high-quality labeling deliverables, including consistency, alignment with data, and adherence to regulations
• support the global labeling strategy and target labeling development
• assist in audits and inspections related to labeling processes

Warszawa - Oferty pracy w okolicznych lokalizacjach