Opis:
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 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 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
11 lut 2025;
from:
www.jobs.pl