Full time position
The main responsibilities will be, but are not limited to, writing and reviewing IMPD and IND submissions to support clinical/pivotal trials, regulatory authority communications, contributing to regulatory strategy, providing regulatory guidance to project teams and project management.
The Regulatory Specialist will report directly to the Regulatory Manager.
Depending on experience the regulatory specialist will be responsible for EU and/or US regulatory activities to:
- Draft, review and maintain regulatory submissions in support of Glycostem’s ATMP clinical trials (IMPD/IND).
- Ensuring that the content, quality, and format of regulatory submissions complies with applicable regulations and guidelines
- Support the timely responses to questions and other regulatory authority communications (e.g. Scientific advice (EMA/FDA) orphan drug requests and annual reporting, PRIME applications, etc.). Maintaining a positive relationship with internal and external contacts
As a Regulatory Specialist, you will
- Support the development of global regulatory strategies and implementation plans for the preparation and submission of new products, ensuring regulatory project timelines are aligned across Glycostem’s departments
- Provide regulatory support/guidance to cross functional teams and stay up to date with relevant guidance and regulations ensuring timely communication of changes.
- Develop/maintain internal processes to facilitate compliant dossier life cycle management
- Support the regulatory release of products to clinical trials and assessment of changes.
- Contribute to continuous improvement activities.
Education, skills and experience
- Bachelor’s degree and 2-5 years demonstrated regulatory affairs experience (clinical IND/IMPD - Biologics or ATMP preferred)
- +3 years additional relevant experience but latest being regulatory
- Familiarity with EU and/or US clinical legislation procedures (IMPD/IND) and guidelines governing Biologics/ATMPs.
- Strong computer skills, project management skills, and a high attention to detail
- Team player, with experience working in cross-functional teams, that can work independently with good organization and time management skills and ability to manage tight timelines when required
- Outstanding communication skills, both verbal and written in English.
Experience of ATMP/Gene and Cell therapies, eCTD, EU and/or US clinical trial trials , Lean 6 Sigma and GMP are an advantage.
Conditions of employment:
- After a successful probation period a permanent contract is extended;
- Competitive salary
- Pension premium contribution;
- Travel allowance or public transport reimbursement;
- 25 holidays; and
- Holiday pay.
Do you have what it takes?
Please apply by sending your cover letter and CV in English to Liana van Genuchten (HR@Glycostem.com). We will reply to you within 3 working days.
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.