14 jobs voor regulatory affairs manager gevonden

Contact with Belgian authorities (participating on inspections, declarations & reporting, license requests)..Investigate queries with local authorities..

The Opportunity As the Regulatory Affairs Manager Benelux and Ireland you are responsible for arranging the provision of regulatory expertise and execution of regulatory strategy & activities including contact with and submissions to the local Health Authorities, management of product information and artwork.Ensure regulatory compliance with Astellas policies, regional/ local regulations and the registered dossier including review/approval of promotional materials.Hybrid Working At Astellas, we recognize that our employees enjoy having a balance between their professional and home lives.

The Opportunity As the Regulatory Affairs Manager Benelux and Ireland you are responsible for arranging the provision of regulatory expertise and execution of regulatory strategy & activities including contact with and submissions to the local Health Authorities, management of product information and artwork.Ensure regulatory compliance with Astellas policies, regional/ local regulations and the registered dossier including review/approval of promotional materials.Hybrid Working At Astellas, we recognize that our employees enjoy having a balance between their professional and home lives.

The candidate will also liaise withEUAf.ME, CLAR and APAC regulatory staff to support other global registration and product maintenanceactivities where appropriate.The candidate will liaise with VMRA Regulatory Chemistry Manufacturing andControl (CMC), Laboratory Sciences, Global Biological Research, Global Therapeutic Research, CommercialDevelopment, Global Manufacturing, Project Management, and other partner groups to drive regulatoryactivities consistent with approved Company objectives.Key responsibilities:Assemble renewal and variation dossiers for biological veterinary products and coordinate/support subsequent responses to Authority questions.

Ensure our complete product offering is compliant with the relevant legislation..provide regulatory input on new product developments..For this you work in a project based environment.carry out other related regulatory affairs missions, e.g.

Opvolgen – behandelen en rapporteren van klachten, bijwerkingen, recalls, afwijkingen, changes, out of specificaties….Regulatory Affairs.

Key Responsibilities

• Periodical Account Closings: Oversee the entire process of periodical closings, from the initial planning stages to the final approval and submission of consolidation packages to the Head Office.
• Regulatory Compliance: Stay up-to-date with evolving accounting and taxation regulations, ensuring compliance with both local and international standards (BGAAP and IFRS) in collaboration with specialized teams.
• Financial Reporting: Prepare and submit comprehensive internal and external accounting and taxation reports, along with other mandatory financial documents required by authorities.
• Tax Management: Manage all aspects of corporate income tax, VAT, and other taxes, including the filing process, prepayments, and coordination of inspections.
• Fiscal Affairs: Oversee the fiscal responsibilities for our operations in France.
• Internal Controls: Implement and maintain robust internal controls within accounting processes to ensure compliance with regulatory frameworks such as SOX.
• Accounts Payable: Supervise the accounts payable function, including the implementation of e-invoicing in accordance with legal requirements.
• Intercompany Services: Manage the recharge process for services provided by the Belgian branch to other entities within the group.
• OPEX Planning and Forecasting: Lead the planning and forecasting activities related to operating expenses.
• This position is based in Brussels.After an initial integration period of four months, there will be an opportunity to work remotely.

Initieel als 'Investigator' en na het opdoen van ervaring, als 'Study Director'; * Binnen GLP ben je verantwoordelijk voor opvolging en beheer van temperatuursregistraties; * Je zal een belangrijke rol spelen bij de implementatie van ISO17025 in het laboratorium; * Je biedt wetenschappelijke ondersteuning aan onze R&D, Regulatory Affairs, Product Management, e.a Deze job is een combinatie tussen administratief werk & labo werk.

Supporting Quality departments in relation to Regulatory affairs..

Opvolgen van reglementering over persoonlijke beschermingsmiddelen..Coördinatie van de interne flow..Audits uitvoeren.. Uitvoeren van jaarlijkse nacontroles in binnen en buitenland..Opvolgen van normen, nationale en internationale wetgeving..

Regulatory Affairs personnel (in house).Coordinating efforts with international division staff to.resolve product/clinical issues involving international customers.

Samen met je collega’s binnen ons team ligt er een gevarieerd takenpakket op jou te wachten:

• Je voert analyses uit in ons  Chemisch lab;
• Je biedt ondersteuning bij het ontwikkelen en valideren van analysemethodes;
• Je bent een actief lid van ons GLP kwaliteitssysteem.Initieel als ‘Investigator’ en na het opdoen van ervaring, als ‘Study Director’;
• Binnen GLP ben je verantwoordelijk voor opvolging en beheer van temperatuursregistraties;
• Je zal een belangrijke rol spelen bij de implementatie van ISO17025 in het laboratorium;
• Je biedt wetenschappelijke ondersteuning aan onze R&D, Regulatory Affairs, Product Management, e.a

Deze job is een combinatie tussen administratief werk & labo werk.

Je staat in voor het management van jouw team, waarbij je zowel organisatie als budget voor jouw rekening neemt.Je ontwikkelt uitstekende relaties met Sales, Regulatory Affairs, Productie, en jouw collega’s in Europa..

Assist in planning, coordinating, and executing multi million euro funded (EU )projects (e.g.Ecorefibre, Cisuflo, Wood4Bauhaus), including research and analysis to support development and implementation throughout the European continent..