infarAMA is currently looking for a

Regulatory Affairs Officer

Key responsibilities

Your role as a Regulatory Affairs Officer will be to ensure that products that are registered, manufactured and/or distributed by the Infarama Customer, meet the required legislation.

  • Assist and support the Regulatory Affairs department
  • Prepare, verify and adapt product information
  • Provide scientific support for marketing authorisation dossiers, notifications and technical dossiers
  • Submit registration and notification dossiers to health authorities
  • Manage the life cycle of the client portfolios (variations, renewals…)
  • Proofread leaflets and labeling
  • Evaluation of promotional activities
  • Maintain records and files

Qualified/Responsible Person

Key responsibilities

Your role as a QP/RP will be to contribute to the implementation and optimization of projects of the infarAMA customers. You will be responsible for a variation of aspects within their projects such as:

  • Accomplish QP/RP duties according to the applicable local and EU regulations (RD 14 Dec 2006 – GMP/GDP guidelines): manage and assure continuous improvement of the pharmaceutical quality management system (QMS) and handle quality complaints, rejects, reworks, returns, recalls, change control, deviations and CAPAs
  • Batch certification (QP) and release for sale (RP) as primary and back-up QP/RP
  • Perform GMP/GDP compliance gap analysis and interact with other departments
  • Participate in GMP/GDP/QMS self-inspections and external audits
  • Ensure inspection readiness and act as primary contact during Competent Authority inspections
  • QA liaison with contract manufacturing organizations or third party logistic providers

Required profile

  • Scientific degree ((industrial) pharmacist, biomedical sciences or equivalent by experience)
  • 1 to 3 years of relevant experience in a similar function in the pharmaceutical industry
  • Ability to take up RP, QP or RIP responsibility is an asset
  • Fluent in English, Dutch and French with excellent oral and written communication skills
  • Strong knowledge of current software
  • Enthusiastic, meticulous, methodological, flexible and reliable
  • Able to work both independently and in teams

Required profile

  • 5 years of working experience in (non-)sterile manufacturing, packaging and labeling and supply chain is an asset
  • Industrial Pharmacist, FAMHP certified (RD 14/12/2006 art. 48/EU Dir. 2001/83/EC)
  • Knowledge of GMP/GDP/risk management
  • Learning attitude and continuous improvement mindset
  • Problem solving capabilities
  • Result driven, accurate (eagle eye for details)
  • Excellent organizational and planning skills
  • Team player
  • Customer oriented (good communicator and assertiveness)
  • Fluent in English and Dutch and/or French

Offer

  • A varied job with challenging multi-disciplinary tasks in a dynamic and growing environment
  • Competitive benefits and compensation packages
  • Workplace in Aarschot or in Strombeek-Bever

Applications

Interested? Send your resume and application letter to p.vandenweghe@infarama.be.

For more information, feel free to contact us.