Regulatory Manager

Regulatory Manager

Job Title: Regulatory Manager
Contract Type: Permanent
Location: Oss
Salary: TBD on Application
Start Date: 2020-01-09
Reference: V-45745
Contact Name: Alex Butcher
Contact Email:
Job Published: January 09, 2020 11:10

Job Description

An exciting opportunity has arisen with a Netherlands based Stem Cell company. Their patented protected technology is based on the expansion and differentiation of stem cells derived from umbilical cord blood. They have several assets in oncology, one due to move into phase II stages. Due to growth within the company they are seeking a Regulatory Manager to join their team.

The successful candidate will ensure that their cell and gene therapy products have an established, and efficient global regulatory strategy that aligns pharmaceutical product development timelines, product authorisations and budget. As well as being responsible for rolling out and coordinating regulatory approval related activities, both internally and with regulatory authorities.

• Write and maintain IMPD for all products
• Coordinate writing and approval of regulatory required documentation
• Coordinate regulatory submissions
• Review and approval of the rationale and regulatory impact assessment related to any potential (substantial) changes to the product, manufacturing process, analytical methods of products under the Pharmaceutical Quality System
• Overall responsible for product approval timelines coordination

Suitable candidates will need to possess skills/experience in the following areas: -
• Several years of regulatory experience within ATMP or industrial biopharmaceuticals
• Ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations