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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.