Regulatory Affairs OfficerOffer by Large Company/SME
Bone Therapeutics S.A is a fast growing biotech company specialized in the treatment of bone diseases using cell therapy. At the forefront of science and medicine and leader in its field, the Company develops innovative cell products for the repair and regeneration of bone tissues, using its proprietary stem cell-based technology platform. With a broad portfolio of advanced clinical (phases II and III) and preclinical programs, the Company is organized as a « mini-pharma » with departments of preclinical, production, quality control& assurance, clinical development, regulatory and administrative.
To strengthen our growing organization, Bone Therapeutics is looking for a « Regulatory Affairs Officer » (M/F). You will be in charge of the development, coordination, follow-up and strategic and operational management of regulatory activities associated with our activities (clinical trials, human biological materials, centralized procedures…), at both national and international levels.
You will be in charge of:
- Preparation, writing, review, completion, and update of documents, dossiers and applications for clinical trials and marketing approval (as well as maintenance, renewal, follow-up, and post-approval tasks), including but not limited to scientific advice, protocol assistance, briefing document, CTA, IMPD, eCTD, IND, BLA, NDA, orphan drug designation, PIP, briefing/meeting packages and responses to Health Authorities, safety reports, protocols and amendments, annual reports, and any other regulatory documents.
- Preparation, conduct, and follow-up of submissions to local, national, and international regulatory bodies, such as European national Competent Authorities, FDA, EMA, notified bodies, and Ethics Committees; development of strong relationships and proactive interactions with such regulatory bodies
- Provide regulatory input for and appropriate follow-up to inspections and audits
- Identify, analyze, and communicate regulatory trends, including proposed, new, or changing requirements, as well as current and pending approvals, with review of their implications for the company
- Develop and implement regulatory strategies, programs, and processes, including support in preparation, writing, and update of Standard Operating Procedures and other internal regulatory file documentation, to ensure compliance with regulatory requirements
- Provide strategic input, support, and technical guidance on regulatory issues to development teams
- Relationships: the Regulatory Affairs Officers report to the Chief Executive Officer
Nr of positions available : 1
Biological sciences - Biological engineering
Early stage researcher or 0-4 yrs (Post graduate)
Recognised Researcher (R2)
Comment/web site for additional job details
- Master/PhD in Biomedical Sciences or Pharmacy
- Minimum of 1 year experience in Regulatory Affairs environment
- Good knowledge of national and European laws, guidance, and regulatory requirements
- Understanding of drug development process, quality systems, clinical trials, and scientific issues in cell therapy
- Strong interpersonal and communication skills
- Excellent verbal and written communication and presentation skills
- Able to work within a small but quickly growing structure
- Reactive to deadlines, pro-active, dynamic and resistant to stress
- Fluent in French and English; Dutch is an asset.
- Immediate start
- Long-term contract (CDI)
- Position based in Anderlecht (Brussels)
To better plan and organise their stay in a foreign European country, researchers and their families can also benefit of the free and personalised assistance offered by the EURAXESS Services Centres, a network of more than 200 centres located in 40 different European countries.
BONE THERAPEUTICS S.A.
Rue Adrienne Bolland 8
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