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Senior Regulatory Affairs Manager/ Associate Director (M/F)
September 10th 2020
Bone Therapeutics SAis a biotechnology company specializing in the development of cell therapy products for bone fracture repair and fracture prevention. At the forefront of science and medicine and leader in its field, the Company is developing innovative regenerative products, containing bone-forming cells, using its proprietary stem cell-based technology platform. With its strong portfolio of clinical programs (Phase II and Phase III) and preclinical programs, Bone Therapeutics is organized as a “mini-pharma”, with departments for preclinical research, clinical studies, production, quality control, quality assurance, regulation and administration.
Mission Description
You will be in charge of:
Regulatory activities:
- Provide regulatory expertise and guidance for new product development and help develop regulatory strategy for EU and US
- Responsible forRegulatory submissions including preparationand/or reviewof CTAs/briefing documents, IMPD, IND, clinical protocol,except for CMC matters, for various projectsincluding ATMP
- Prepare and distribute regulatory agency contact reports and meeting minutes
- With oversight, conduct QC and QC checks of materials prepared by the regulatory unit, project team or external on regulatory compliance
- Ensure completeness of regulatory information to be included in clinical trial.gov and EudraCT form with clinical study manager;
- Direct the preparation and submission of regulatory agency applications, reports, or correspondence
- Support preparation of tracker in order to define the list of potential issues raised by Agencies during clinical trials and scientific advice to allow to define the optimal strategy by Regulatory lead
- Develop regulatory strategies and implementation plans for the development as well as preparation and submission of regulatory documents
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts on Bone Therapeutics projects and internal policy.
Regulatory team activities
- Arrange meetings of project teamsfor regulatory matters except for CMCor regulatory agency
- Increase knowledge of regulations and guidelines,communicate regulatory information to multiple departments and ensure that information is interpreted correctly
- Assist with project management, and other tasks as required by regulatory team members
- Attend regularmeeting including project team with all stakeholders and disciplines from R&Dand management
- Prepare Regulatory Risk mitigation for regulatory disciplines except CMC
- Train staff in regulatory policies or procedures
- Develop and maintain standard operating procedures or local working practices
- Establish regulatory priorities or budgets and allocate resources and workloads
- Contribute to the development or implementation of business unit strategic and operating plans
- Monitor regulatory affairs activities to ensure that they are aligned with corporate sustainability or green initiatives
- Line management with growing of regulatory department
- Ensure that resources estimate is accurate to allow recruitment in due time.
Candidate profile
Expected experience
- Master/PhD in Biomedical Sciences or Pharmacy or equivalent
- Minimum of the 7yearsexperience in Regulatory Affairs environment
- A knowledge in ATMP regulation is an added value
- Good knowledge of internationalguidance and regulatory requirements
- Applying domain knowledge: Merely possessing knowledge is not the key. Knowing how to apply domain knowledge in the field of regulatory framework development is very important
- Project management skills: Product development life cycle ina complex project
- Understanding of drug development process, quality systems, clinical trials, and scientific issues in cell therapyand other innovative products.
Soft skills
- Strong interpersonal and communication skills
- Excellent verbal and written communication and presentation skillsin both English and French
- Able to work within a small but quickly growing structure
- Problem Solving: You should be able to resolve the most complicated problems that may arise in the course of product development
- Analytical skills: You should know how to take decisions based on facts and figures rather than on assumptions
- Well organized
- Priority settings
- Team player
- Able to work in multicultural environment
- Flexible
- Resistant to stress and changes in strategy
- Able to travel based on business needs
- Fluent in English (oral and written)Medical writing skills is an asset
Offer
Offer:
- Immediate start
- Full-time
- Long-term contract (CDI)
- Position based in Gosselies (Wallonia).
Contact Details
This opportunity to join a dynamic quickly growing companysounds appealing to you? You want to be involved in the development of innovative research products with medical applications? Then, do not hesitate further, and send your detailed CV and an application letter toMrs. Roels: hr@bonetherapeutics.com
Notice to Agency and Search Firm Representatives
Bone Therapeutics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Bone Therapeutics employee by a third party agency and/or search firm without a valid written & signed search agreement,will become the sole property of Bone Therapeutics. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
