ASIT Biotech is a Belgian clinical-stage biotech company focused on the development of breakthrough immunotherapy products for the treatment of allergies.
Thanks to its innovative technology platform, ASIT Biotech currently holds a leading and unique position on the market. This innovation results in a short treatment, expected to improve patient compliance and quality of life. ASIT Biotech’s product pipeline targets to significantly expand the current immunotherapy market. For more information about the company, please vist www.asitbiotech.com.
With a headcount of 25 staff members, ASIT Biotech is located in Liège, Belgium. In order to support its high-potential developments, we are looking for a (m/f):
Head of Regulatory Affairs
As a Head of RA, you lead and drive the execution of ASIT global regulatory and quality assurance strategy. Reporting to the CEO, you are responsible for regulatory affairs, quality assurance, and compliance activities across the company. You define and implement the quality and regulatory policies in line with applicable directives, guidelines and legal requirements.
Your main responsibilities are as follows:
- Develop, propose and implement the company regulatory & quality strategy.
- Manage regulatory documents submissions for clinical studies, and product approvals.
- Implement an efficient quality system and a continuous improvement culture within the company.
- Interact with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and follow-up of
- Support and advise project teams on regulatory and quality issues.
- Provide technical review of data and reports for regulatory submissions.
- Draft product labelling, instruction leaflets and packaging.
- Participate in internal/external audits, inspections and provide post-inspection
- Write and update SOP, work instructions, and policies.
- Master or PhD in life sciences or equivalent through experience.
- 10 years experience in a RA and/or a QA management position in the Biotech/Pharma sector.
- Track record in developing quality systems from EU/US clinical developments to product approval.
- Thorough knowledge of ICH guidelines, GxP and related regulatory guidances.
- Proven track record of building strong relationships with internal and external stakeholders.
- Ability to maintain multiple projects and meet timelines, including change management skills.
- Client-centered and solution-oriented, with hands-on and pragmatic mindset.
- Excellent leadership, communication and interpersonal skills.
- Familiar with MS Office solutions.
- Fluency in English.
- A challenging leading position within a stimulating and dynamic work environment.
- A variety of interesting contacts with international exposure.
- The opportunity to have direct impact on the results of a high-potential biotech company.
- An attractive compensation package in line with the position responsibilities and your experience.