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Labeling Manager Rest of World

Vacaturenummer: A2200081
Astellas Pharma Europe B.V. - Leiden (Nederland)

For our client, Astellas Pharma Europe B.V., we are looking for a Labeling Manager Rest of World.

Keywords

  • Regulatory Affairs
  • Pharma
  • Labeling
  • FDA/ICH
  • Change control


Profile
As Labeling Manager you are responsible for the development, implementation, and change control of new and revised labeling for products and areas within the Rest-of-World (ROW) region. You will ensure compliance with Company Core Data Sheets, applicable regional health authority requirements, and internal procedures and alignment with business needs. You investigate government initiatives related to labeling and packaging, and assure that Astellas adopts new initiatives according to prescribed timelines.
Essential job responsibilities:
  • Drive labeling development for regional product launches and ensure that all labeling meets company and regulating health authority specifications;
  • Manage English Master files and translation of text into local languages according to individual country requirements (where appropriate);
  • Serve as leader of cross-functional labeling review team meetings; organise, compile, and maintain all documentation and assure compliance of manual and electronic label history files;
  • Assure compliance of local labeling by evaluating all CCDS/CCSI changes and implementing according to prescribed timelines;
  • Advise cross-functional teams on labeling content consistency and best practices regarding planning and execution;
  • Collaborate with Regulatory Affairs cross-functional teams on submission and implementation strategy for labeling;
  • Actively support the systems, processes, and operations for development of and changes to labeling, and assure compliance to those procedures;
  • Establish strong working relationships with global stake holders, affiliates, and business partners to assure compliant and timely implementation into business supply;
  • Make and execute challenging decisions based upon sound regulatory knowledge, but also recognise when a decision should be elevated to upper management for further consideration;
  • Keep management apprised of critical issues which may impact the success of the organisation.


Who we're looking for
The ideal candidate has an M.Sc. with at least 6 years of industrial experience of which at least 3 years in RA. You have scientific knowledge chemistry, general biological/physical science and ability to apply that knowledge to regulatory issues and product development having technical complexity. Additionally, you have direct pharmaceutical labeling development experience, with demonstrated proficiency in managing change control.
Other requirements are:
  • Proven proficiency with relevant FDA/ICH and other local health authority regulations & guidelines for labeling development, implementation, and compliance requirements;
  • Proven effectiveness with stake holders in the labeling system from content development through commercial supply;
  • Must be able to effectively influence peers and others, both inside and outside the organisation, and maintain effective working relationships;
  • Strong organisational skills and high level of attention to detail, with the ability to co-ordinate multiple large and diverse projects simultaneously;
  • Excellent written and verbal communication skills (English required, Dutch and/or Spanish are advantageous).


Company profile
Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide 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 worldwide through the provision of innovative and reliable products. Astellas employs around 950 persons in the Netherlands, in Leiden and Meppel.


Additional vacancy information
Reference:A2200081
Contract:Temporary contract with CLS Services
Education:WO/MSc. HBO/BSc. PhD.
Publication date:23-6-2022
Location:View location with Google Maps
Contactperson:Aniek Vugts
+31 (0)88 22 77 555

CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.