Regulatory Affairs Associate Labeling

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands.

This international pharmaceutical company is located in Noord-Brabant and is lookig for Regulatory Affairs Associate. This is an ideal starters position within an interesting pharmaceutical company. You will be trained to do your daily tasks and you will support the Regulatory Affairs managers. This is a temporay position for atleast 12 months and a good start for your pharmaceutical career.

ROLE DESCRIPTION

The RAGLO staff member is responsible for understanding and complying with the labeling regulations and guidance’s for the regions they support. RAGLO staff is responsible to provide guidance to effectively integrate regional labeling processes into Global Labeling processes. Under supervision of the RAGLO department head, the RAGLO staff member supports the development, review, approval and maintenance of all package component labeling documents for all products derived from core package component labeling and is responsible for ensuring the alignment with the core labeling and documenting any deviations.

RESPONSIBILITIES

• Maintain awareness of regional regulatory legislation and guidance pertaining to commercial labeling.
• Support the development, review and approval of country regional text lists (cRTLs)
• Assist in development, review and approval of source text provided as product regional text lists (pRTLs) or annotated PDF’s for package component labeling and ensures it is aligned with core package component labeling. Identified deviations to the core are brought to the appropriate governance body for justification and are documented.
• Review and approval of Artwork Request Forms (ARFs).
• Perform Label Product Tracker (LPT) updates for tracking ARFs and source text handoffs.
• Interface with regions (affiliates/regional hubs) and artwork centers to ensure adherence to the Global Text and Artwork generation (GTAG) process (timelines, source text authoring guidelines, etc).
• Ensures representative mockup is available on time to support regulatory filings and implementation requirements for conversion to master labels.

REQUIREMENTS

Basic Qualifications:
• Bachelor degree
• Ability to multi task and support a diverse internal customer base
• Experience with working in a highly regulated environment
• Fluent in English both writing and speaking

Preferred Qualifications:
• Working knowledge of regulatory and pharmaceutical processes
• Ability to evaluate and adhere to company operating procedures as well as hold other accountable to SOP adherence.
• Takes ownership in driving tasks and project deliverables to completion
• Communicates in a clear, concise and timely manner to clients’ requests
• Basic Skills in Excel and Word

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact .