Labelling Artwork Manager
Astellas Pharma Europe B.V. - Leiden (Nederland)
For our client, Astellas Pharma Europe B.V., we are looking for a Labelling Artwork Manager.
As Labelling Artwork Contractor, you are responsible for development, implementation, and change control of new and revised labeling for assigned Astellas products and areas within the Rest-of-World (ROW) region. You ensure compliance with Company Core Data Sheets, applicable regional health authority requirements and internal procedures. Researches government initiatives related to labeling and packaging, and assures that Astellas adopts new initiatives according to prescribed timelines. Requires significant interaction outside the Regulatory Affairs department on complex issues and questions. Maintains a positive working relationship with global internal stakeholders and business partners.
- Drives labeling development for regional product launches and ensures that all labeling meets company and regulating health authority specifications;
- Manages English Master files and translation of text into local languages according to individual country requirements (where appropriate);
- Serves as leader of cross-functional labeling review team meetings; organizes, compiles, and maintains all documentation and assures compliance of manual and electronic label history files;
- Assures compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines;
- Advises cross-functional teams on labeling content consistency and best practices regarding planning and execution;
- Collaborates with Regulatory Affairs cross-functional teams on submission and implementation strategy for labeling;
- Actively supports the systems, processes, and operations for development of and changes to labeling, and assures compliance to those procedures;
- Establishes strong working relationships with global stakeholders, affiliates, and business partners to assure compliant and timely implementation into business supply;
- Makes and executes challenging decisions based upon sound regulatory knowledge, but also recognizes when a decision should be elevated to upper management for further consideration.
Who we're looking for
The ideal candidate has a B.Sc. with at least 6 years previous industry experience of which 3 years in Regulatory affairs. Direct pharmaceutical labeling development experience with demonstrated proficiency in managing change control is required. You have proven proficiency with relevant FDA/ICH and other local health authority regulations & guidelines for labeling development, implementation, and compliance requirements. We are looking for someone with excellent communication and organisation skills, with a high level of attention to detail. Do you have the ability to prioritise your work and multitask ? Then we are looking for you!
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people world-wide with global sales exceeding 11 billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people world-wide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Employment terms||:||Salary: > 3100|
Days of leave: 25 + 13
Project for at least 1 year
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
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