Regulatory Submission Manager
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Astellas Pharma Europe B.V., we are searching for a Regulatory Submission Manager .
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.
Are you a strong organized, regulatory affairs professional with experience in key regional health authority regulations? Are you able to play a key role in an international organization and define and support the submission portfolio management process across multiple products and therapeutic areas? Then We have an interesting job opportunity for you!
As Submission Manager, you are responsible for the coordination of the collection, organization and dissemination of submissions and related regulatory information. This role provides broader visibility to changes in the regional or in some cases global product portfolio and is the central point of knowledge related to operational status and execution responsibilities. You identify changing regulatory guidance and anticipate impact on submission preparation and processing other information management activities. While managing multiple projects you accurately document change and ensure all approval requirements are met before releasing product quality, patient safety, and in some cases, product sales.
Your focus will be on the EMEA region but you will liaise with global colleagues, senior management and global and regional Project Teams. You address complex and diverse informatics challenges with decision-making that impacts multiple projects, functional areas and therapeutic areas. Within Astellas you are the person whom others can ask about submission plans and other operational aspects of a product or product portfolio.
Who we're looking for
The ideal candidate has a Bachelor#39;s degree in a scientific disciple and at least 3 years industry experience in Regulatory Operations or in a role closely associated with interpretation of health authority regulations, product change control, labelling, submission publishing/dispatch, or registration tracking. You are familiar with key regional Health Authority regulations, interpreting regulatory guidance and monitoring the external regulatory. Also, you are familiar with environment for changes that impact submission standards or other regulatory practices
Additionally, you have experience with:
- eCTD, NEES and other technical submission formats;
- one or more European procedure types, e.g. CP, MRP/DCP;
- lifecycle maintenance, submission management and document management concepts.
As a person you are a disciplined project manager and are able to track various tasks and regulatory requirements. Success will be measured in large part by the timeliness and accuracy of maintenance submissions to multiple health authorities within the EMEA. The role expects proactive collaboration and effective communication. As a Submission Manager you have strong organizational skills, a high level of attention to detail and you are able to manage multiple diverse projects simultaneously.
Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Position for at least one year.
Contactperson: René Kemps
Phone: +31 (0)88 22 77 555