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Regulatory Affairs Manager (H/F/X)

January 27th 2021

Bioxodes, a pioneering Belgian clinical-stage biotech company specialized in the development of innovative therapeutics to prevent thrombosis and inflammatory processes. The Bioxodes’ lead drug candidate, Ir-CPI, is a unique antithrombotic molecule which has the uncommon properties to inhibit both initiation factors involved in the intrinsic pathway and in the contact phase of coagulation, and cellular components associated with the formation of blood clots. Bioxodes’ clinical program for its lead product candidate, Ir-CPI, includes Phase I/IIa trials studying Ir-CPI for the treatment and prevention of thrombo-inflammatory diseases. The Company is building a pipeline of additional product candidates targeting the activation of neutrophils which are key players in numerous inflammatory events.

Mission Description

 

  • Build and maintain excellent relationships with competent regulatory authorities (national/international) and internal stakeholders. Representation of the Company to health authorities.
  • In collaboration with a Regulatory Consulting company, direct the preparation and submission of regulatory agency applications, reports, correspondence, and meeting minutes. Provide responses to regulatory agencies regarding product information or issues.
  • Coordinate and follow all regulatory submissions (CMC, non-clinic and clinic) and approvals at all stages of the medicinal product development according to given timetables. Maintain full responsibility of all regulatory activities on assigned projects and prioritize activities to ensure completion of goals. Work to minimize regulatory issues and help prevent unnecessary delays.
  • Monitor the whole regulatory approval process identifying critical steps and suggesting optimization actions.
  • Respond to technical and scientific regulatory affairs (RA) questions. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products. Communicate regulatory information to departments and ensure that information is interpreted correctly.
  • In coordination with CMO, develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Implement or monitor complaint processing systems to ensure effective and timely resolution of all complaint investigations. Investigate product complaints and prepare documentation and submissions to appropriate regulatory agencies as necessary.
  • Maintain current knowledge of relevant regulations, including proposed and final rules.
  • Help in the development or implementation of regulatory affair policies and procedures to ensure that regulatory compliance is maintained or enhanced. When required, train staff in regulatory policies or procedures.
  • Manage activities such as audits, regulatory agency inspections, or product recalls.

Candidate profile

  •  Required Education: Master or PhD in Life Sciences with relevant training in Regulatory Affairs or Clinical Pharmacist in Pharma Industry and/or in Regulatory Affairs.
  • Fluency in French and English, Dutch is an asset.
  • Minimum of 5 years of experience in Regulatory Affairs environment.
  • Excellent knowledge of international guidance and regulatory requirements, successful track records in CTA. Experience with national/international Health Authorities is an asset.
  • Good communication, organization, and negotiation skills.
  • Excellent administrative management skills.
  • Cross functional team player
  • Very detail oriented and analytical skills.
  • Able to work with strict deadlines.
  • Result driven mindset (excellent problem solving & project management skills).
  • Manage workload and unpredictable issues, requiring organizational skills.

Offer

  • Immediate start.
  • Full-time position with permanent contract (CDI).
  • Attractive salary conditions will be offered.
  • This role will be home-based during COVID-19 pandemic, then office-based (Gosselies, Belgium).

Contact Details

Please send a CV, covering letter explaining your suitability for the position and contact details for 3 referees. Applications should be sent by e-mail to: info@bioxodes.com.
No UNSOLICITED PHONE CALLS OR E-MAILS PLEASE. Only candidates who are deemed a close fit will be contacted. All pertinent CVs will be maintained for a duration of maximum 6 months.