Vacature Regulatory Affairs Manager for the Netherlands and Switzerland - The Netherlands and Switzerland

Functie: Regulatory Affairs Manager
Regio: Internationaal

Bedrijfomschrijving

Onze opdrachtgever is een wereldwijd farmaceutisch bedrijf gespecialiseerd in onderzoek, ontwikkeling en marketing van therapeutische en esthetische oplossingen voor patiënten in de preventie, de diagnose en de behandeling van dermatologische aandoeningen. Zij focust zich uitsluitend op dermatologie met als doel de huid te herstellen en gezond te houden. Zoals de huid op een unieke manier functioneert binnen het lichaam, vereist dermatologie gespecialiseerde kennis en vaardigheden. Onze opdrachtgever profileert zich als innovator in de dermatologie en wijdt zich daarom volledig toe aan dit specialisme.

Functieomschrijving

The core mission of the Regulatory Affairs Manager is:

  • Lead and manage the local registration process in ensuring approvals of new products, manufacturing permits, import permits, and amendments (variations, 5 year renewal, post-approval commitments) to products in the Netherlands and Switzerland.
  • Price and reimbursement dossiers
  • Monitor pharmaceutical laws and ensure operational compliance (advertising, packaging, samples, pharmaceutical SOPs, etc.)

The duties and responsibilities of the Regulatory Affairs Manager are:

  • To manage timely submission, follow-up and approval of new marketing authorizations, variation and renewal applications in the Netherlands/Switzerland als well as PSUR submissions in line with the legal requirements
  • To ensure regulatory compliance of pharmaceuticals, medical devices & cosmetics in the Netherlands
  • To ensure information feedback towards the Regulatory & Medical Affairs Manager Benech on Marketing Autorization submissions, new legislations
  • To support and manage the consultant in Switzerland on regulatory affairs
  • Filling and amendments of marketing authorization applications including:
    • Obtain relevant marketing authorization with local authorities in a timely manner
    • Assessment, review and management of marketing authorization applications
    • Coordinate translations of SPC's, labelling and package leaflets in French, German & Italian for all products
    • Answer to questions/comments from the authorities with the support of Regulatory Affairs Corporate
    • Follow-up the status of submissions and approval with the Medicine Evaluation Board (CBG/MEB)
    • PSUR's submissions and transmission to Pharmacovigilance Responsible
    • Manage the budget for MA & Variation submissions
    • Stay up-to-date with current local regulatory requirements and inform the RA and Medical Affairs Manager
  • Ensure that all necessary regulatory adequate procedures are in place to assure the pharmaceutical responsibility
  • Act as 'Responsible Pharmacist' function and 'Quality Assurance Responsible'
  • Handle the administrative release of the products in order to sell the product
  • Review all packaging artworks from a regulatory perspective as per internal and corporate SOPs in place
  • Liaise with Corporate for Trademaks and other related legal issues
  • Represent the company in the relevant committees of the professional associations
  • Support the constitution of reimbursement dossiers, including pharmaco-economical data management, liaise with Corporate Management
  • Set-up price & reimbursement dossier including contacts with authority
  • Review of all promotional activities (materials, sampling reporting to government, congress visa and promotional literature)
  • Develop and maintain positive relationships with health authorities
  • Obtain import permissions with legal authorities
  • Obtain manufacturing licenses for products intended to be manufactured at local suppliers (if any)
  • Complaint handling, act as back-up Local Complaint Officer

Functie-eisen

The profile requirements of the Regulatory Affairs Manager:

  • University Degree, preferable as pharmacist
  • Fluent in Dutch, German and very good business English
  • Minimum of three years experience in Regulatory Affairs & Price/Reimbursement, by preference pharmaceuticals & medical device
  • Good knowledge of pharmaceutical industry & local healthcare system
  • Familliar with national pharmaceutical legislations and Pricing & Reimbursement regulations

The skills of the Regulatory Affairs Manager:

  • Rigorous, correct
  • Independent, responsible
  • Convincing
  • Communication skills

Solliciteren

Heb jij interesse in deze functie als Regulatory Affairs Manager for the Netherlands and Switzerland voor Internationaal? Neem dan contact op met Irene Houtsma bekijk op linkedin via onderstaande sollicatie knop of bel naar 038-455 62 62..

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