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Regulatory Operations Associate

Vacaturenummer: A2100032
Astellas Pharma Europe B.V. - Leiden (Nederland)

For our client, Astellas Pharma Europe B.V., we are looking for a Regulatory Operations Associate.

Keywords

  • Junior role
  • Regulatory Affairs
  • Electronic document management
  • Regulatory Agencies
  • Checking documentation


Profile
This job description applies across the four subsections within Regulatory Operations: Regulatory Information, Publishing, Document Management and Style Compliance. As Regulatory Operations Associate, you are expected to be a specialist in at least one of the 4 key areas and should have the basic knowledge in at least one other area.
Responsibilities will include timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of such and document conformance to global publishing standards. You will interact on regional projects with other areas of the Astellas organization, including colleagues at the European affiliates.

Responsibilities:
  • Ensure timely preparation and submission of correspondence and applications to regulatory agencies, tracking and planning of such and document conformance to global publishing standards and style manuals;
  • Responsible for timelines and own resource management. Participates in extended teams/projects/teams. Ensures timely internal communication regarding regulatory filing status;
  • Is considered a specialist in the field of electronic document management & style compliance, submissions management & publishing or regulatory information management;
  • Provides advice on technical quality of submission ready documents and completeness of planning and tracking information;
  • Ensures compliance with Regulatory Agency rules and guidelines pertaining to regulatory (including electronic) submissions;
  • Ongoing maintenance of process documentation associated with Regulatory Operations / Publishing activities;
  • Act as a liaison between members of Regulatory Affairs, QA and Operations in order to ensure timely submission of regulatory compliant, quality documents;
  • Participates in the global testing and piloting of new electronic software tools;
  • Conduct trainings for new users in Regulatory systems and creates job aides, process improvements, and training documentation.


Who we're looking for
For this junior role, we are looking for BSc or MSc candidates with some experience in Regulatory Affairs. You can prioritize your work well and can work independantly on your tasks. Because you work with other project teams in Europe, you have excellent communication skills English, oral and written.

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:A2100032
Contract:Temporary contract with CLS Services
Education:HBO/BSc.
Employment terms:Contract for at least one year.
Salary: >2400
Days of leave: 25 + 13
See here our other employment terms for this vacancy
Publication date:16-2-2021
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.