Regulatory Manager

Vacancy for a Regulatory Manager

Full time position

At Glycostem we are recruiting a Regulatory 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 Glycostem has 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

Education, skills and experience

The job as Regulatory Manager will be held by a person with:

  • 5 - 10 years of regulatory experience within ATMP or industrial (bio)pharmaceuticals
  • Ability to implement complex regulatory details in a simple strategy while adhering to relevant regulations

We offer;

  • After a successful trial period a permanent contract is extended.
  • Competitive salary, after your first year your salary will be adjusted accordingly with your performance and dedication; 
  • Pension premium contribution; 
  • Travel allowance or public transport reimbursement; 
  • 25 holidays.

 

Do you have what it takes?

Please convince us by sending your motivation and CV in English to Liana van Genuchten (HR@Glycostem.com). Selected candidates will be invited for a face-to-face interview with the line management.

Want to know more?

E-mail our HR department at HR@Glycostem.com for more information about Glycostem and the selection process.

Recruiters should not contact us.

Please be aware that your application means that the information you provide will be shared by and with HR and the employees who are involved with the procedure. In case the procedure with you ends, your application and provided information will be deleted within four weeks after the moment you have been informed. Your name and date of application will be registered in our database for statistical use and status only. By applying you agree with and have taken notice of these conditions.

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