Regulatory Affairs Manager

The role entails a broad range of duties and the specific areas of focus will be dependent on the skills and experience of the person holding the role.

The basic responsibility is to ensure that we have an established, maintained, comprehensive and efficient global regulatory strategy that aligns pharmaceutical product development timelines, product authorisations and budget.

Furthermore, the regulatory manager will be responsible for rolling out and co-ordinating the activities related with regulatory approvals, both internally and with applicable regulatory authorities.

The Regulatory Manager will help increase the awareness of relevant regulatory standards and guidance’s throughout the organisation.

Responsibilities

• Maintain good contacts with global competent 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 our products under the Pharmaceutical Quality System
• Functioning as a regulatory point of contact for Glycostem’s external partners, companies, or organisations for oNKord® related regulatory questions
• Informing Glycostem on any potential (upcoming) ATMP regulatory or guidance document changes which may impact oNKord® product development and authorisations
• Overall responsible for product approval timelines coordination