Manager RA Global Labeling Product Leader

Job title:

Manager RA Global Labeling Product Leader

Company:

Randstad

Job description

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.Manager RA Global Labeling Product Leader Nr ref.: 486/1/2025/AT/259402/jobs.pl Warszawa (mazowieckie)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

What we expecteducation:

• 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 47this job offer is intended for people over 18 years of age

Expected salary

Location

Warszawa, mazowieckie

Job date

Sat, 01 Feb 2025 23:36:40 GMT

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