125 jobs voor regulatory gevonden

Als Regulatory Strategist maak je deel uit van een team dat verantwoordelijk is voor het interpreteren van federale, staats en internationale regelgeving en het begeleiden van het bedrijf bij het naleven van deze voorschriften.Je werkt nauw samen met verschillende afdelingen, waaronder productie, laboratoria, QA en supply, om ervoor te zorgen dat de producten voldoen aan de geldende regelgeving.Een belangrijk onderdeel van jouw werk als Regulatory Strategist is het ondersteunen van de reglementaire indieningen voor de producten.

Our client is seeking a passionate Regulatory Officer, keen to help the company develop its Legal & Regulatory department for its activities in Belgium.

Key responsibilities include:

• Managing relationships with regulators, DSOs, industry groups, and other key stakeholders (Law Firms, Consumer organizations, politicians), and actively participating in external meetings.
• Monitoring regulatory changes in the energy sector to support compliance and strategic planning.
• Collaborating with internal teams (Sales, Marketing, Customer Experience, Operations) to address regulatory issues and uncover business opportunities.
• Engaging in proactive lobbying to advance the company's interests and support sustainable growth in the market.

Liaise directly with licensing authorities as needed to achieve objectives.Help assemble new authorization dossiers and help coordinate/support responses to Authority questions.Provide regulatory support for geographic expansion, especially in those cases where geographic expansion activities are concurrent with EU authorisation activities.Serve as regulatory representative on assigned teams responsible for maintaining and geographically expanding veterinary biological products.Help develop and implement the regulatory strategy for assigned teams, with guidance and mentoring from the manager of the biological team.Help provide regulatory support and advice regarding Global Manufacturing initiatives and Commercial market enhancements.Help liaise with US and CLAR/APAC regulatory staff to facilitate global registration activities where appropriate.Bedrijfsprofiel:For our client in Zaventem we are looking for a SR.Associate Regulatory Affairs s who willprovide regulatory guidance and support for regional and global veterinary biological maintenance teams anddevelopment project teams.

Provide customer guidance, monitor customer licenses and regulatory blocks..Act/report proactively when recognizing significant business risks .

.As member of the global regulatory team, you.ensure our complete product offering is compliant with the relevant legislation..provide regulatory input on new product developments..

Heb je bovendien een goed taalgevoel in het Nederlands, Engels en Frans en draag je nauwkeurigheid hoog in het vaandel?Dan is deze job waarschijnlijk echt iets voor jou!Je komt terecht in een farmaceutisch bedrijf regio Hoogstraten op de dienst regulatory affairs.Je belangrijkste taken zijn productregistratie, communicatie met regelgevende instanties in verschillende landen wereldwijd en het begeleiden van productontwikkeling.Als administratief bediende regulatory affairs zorg je voor de registratie van farmaceutische producten voor verkoop in het buitenland.

Accumulate knowledge based on lessons learnt, investigation and literature on potential risks, quality and regulatory requirements and suggest alternatives.Collaborates with internal and external partners to stay abreast of industry trends and emerging risks related to raw materials, regulatory and quality requirements evolution, best practices.

Vivaldis Office zoekt Administratie bediende ondersteuning QA, regulatory affairs

Waar moet je zijn?

• Regio Arendonk 
• Specialisatie: Medisch, Wetenschap, Welzijn 

Hebben we je interesse al gewekt of heb je vragen over deze vacature?Bel/schrijf naar Evelien of Cheyenne!

• Opvolgen en up-to-date houden van de administratieve documenten, opvolging wetgeving/regelgeving/databases/analyses mbt de sector
• Analyseren van de markt 
• Administratie hoort er natuurlijk ook bij: Orderbeheer/verwerking, opmaak klantendossier, ondersteuning accountmanagers met offiertes/prijsaanvragen, prijsvergelijkingen, productgamma opvolgen, beheer kwaliteitsdocumentatie, validatie apparatuur.
• Contact leveranciers + rapportage leidinggevende 
• Ondersteuning QA, borging kwaliteitssysteem, procesoptimalisatie
• Bekomen en behouden van vergunningen/registraties
• Voorbereiding en ondersteuning/begeleiding audits
• Geven van training/ opleiding

As an ALTEN consultant, you will have the opportunity to be part of the following activities:Ensure the release of batches of pharmaceutical products in accordance with local and international regulations Act as the quality assurance representative to approve production activities and associated documentation Perform critical reviews of batch records, including certificates of analysis, manufacturing and control protocols, and test reports Work closely with production, quality control, and pharmaceutical development teams to ensure the quality of pharmaceutical products Ensure that facilities, equipment, processes, and procedures are in compliance with quality and safety standards Participate in incident, deviation, and change management, and conduct quality investigations Maintain a thorough knowledge of local and international regulations related to batch release and regulatory compliance

Develop and maintain clinical development plans, risk management plans, and mitigation strategies to address potential challenges;.Ensure compliance with regulatory and ethical standards in clinical trials, including GCP, ICH guidelines, and applicable regional laws;.

Als Regulatory Affairs Officer maak je deel uit van de afdeling compliance en sta jij in voor de registraties van het productassortiment in het buitenland.Je zal het volledige proces in goede banen leiden zodat de producten uitgeleverd kunnen worden naar alle verschillende werelddelen..

❏ Conduct regular compliance monitoring, considering an array of contextual data including regulation, policies, procedures, controls, training, and governance structures, escalating and assisting in the remediation of any identified gaps..❏ Review Employee surveillance related alerts..

.Advise clients on data governance strategies that support business growth while mitigating risks around data breaches and regulatory penalties. .

Alle Vivaldis collega's zetten zich in voor een gelijke kansenbeleid.Wij selecteren op basis van ervaring, studies en competenties en niet op basis van nationaliteit, uiterlijke kenmerken, geaardheid, religie, handicap, leeftijd en /of geslacht.Onze rol als uitzendbedrijf impliceert het streven naar inclusie en diversiteit.Discriminatie wordt niet getolereerd.

Jobomschrijving

* Opvolgen en up-to-date houden van de administratieve documenten, opvolging wetgeving/regelgeving/databases/analyses mbt de sector
* Analyseren van de markt
* Administratie hoort er natuurlijk ook bij: Orderbeheer/verwerking, opmaak klantendossier, ondersteuning accountmanagers met offiertes/prijsaanvragen, prijsvergelijkingen, productgamma opvolgen, beheer kwaliteitsdocumentatie, validatie apparatuur.
* Contact leveranciers + rapportage leidinggevende
* Ondersteuning QA, borging kwaliteitssysteem, procesoptimalisatie
* Bekomen en behouden van vergunningen/registraties
* Voorbereiding en ondersteuning/begeleiding audits
* Geven van training/ opleiding

Within the international Rainbow program, we are building a new data warehouse for our regulatory reporting to all possible regulators.The way in which we build this is guided by the requirements of the various group functions (Risk, Finance, Credit Risk, Treasury, Sustainability).

Zoek je een uitdagende functie in een hoogtechnologisch bedrijf.Heb je ervaring in een compliance of regulatory functie binnen de biotechnologie of bioprocesindustrie of een vergelijkbare hightechsector?Lees dan zeker verder!

Functieomschrijving
Onze klant regio Tienen is op zoek naar een Compliance Officer Productontwikkeling.


Verantwoordelijkheden

• Het monitoren van de Belgische, Europese en globale wet- en regelgeving met betrekking tot biotechnologie en export van producten.
• Je zal actief samenwerken met het PPD team en de kwaliteitsafdeling om innovaties te ondersteunen binnen de kaders van HACCP en regelgeving.
• Opstellen en valideren van safety, product en feed safety data sheets voor nieuwe productontwikkelingen;
• Identificeren van compliance risico's in productontwikkeling, adviseren van management, QA en PPD over impact van de compliance risico's en van veranderende wet- en regelgeving op de productontwikkeling.
• Ondersteuning bieden aan site compliance voor relevante regelgeving gelinkt met de nieuwe productontwikkelingen.

Regulatory Officer die mee instaat voor de continue verbetering van onze systemen en producten..Wat houd je functie in?.

Als regulatory affairs officer maak je deel uit van de afdeling compliance en sta jij in voor de.registraties van ons productassortiment in het buitenland.buitenland alsook verschillende externe partijen.Deze communicatie verloopt in het Engels.

You will implement robust investigation methods and train the team to effectively handle quality investigations.Quality and compliance: You will ensure that all investigations meet the highest GMP standards and regulatory requirements.You will lead investigations into deviations and support other departments in this process.

You act within professional, legal and ethical boundaries and guidelines, observing all internal and external compliance regulations and code of ethics and conduct, flagging and managing reputational risks and conflicts issues.

Verantwoordelijke voor het document management systeem van interne audits of andere QA activiteiten..Schrijven van Quality reports, metrics & KPI’s.

The KYC Analyst (B2B) is responsible for executing and enhancing the bank's Know Your Customer policies.This role is pivotal in maintaining the bank's regulatory compliance within the financial services sector.

Client Details

The company is a respected entity within the financial services industry.Known for its commitment to innovation and excellence, the company's operations span across several continents making it a truly global entity within the banking and financial services sector.

Description

As a KYC Analyst (B2B), you will have the following responsibilities:

• Performing due diligence checks on new and existing clients
• Updating and maintaining client KYC records in line with regulatory standards
• Collaborating with multiple departments to ensure seamless compliance protocols
• Reporting any suspicious activities in line with the company's procedure
• Staying up-to-date with any changes to financial regulations and legislation

Regulatory Compliance: Ensure that all implementations comply with e.IDAS 2.0, ETSI standards, and other relevant regulations such as ISO and ENISA guidelines, with a particular focus on signing and sealing. .

The Technical Writer will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR-T Operations and document lifecycle management.They will also be responsible to prescribe the correct training based on the type of changes made.

Major Responsibilities:

• Oversight of the revision process of existing SOPs in time to support Manufacturing Strategy.
• Oversight of the introduction of new SOPs in time to support Manufacturing Strategy.
• Ensure Master Batch Record changes are made in time to support Manufacturing Strategy.
• Ensure proper training is prescribed as per the document changes made.
• Liaison with Operations, Technical Operations and QA to ensure alignment of changes.
• Continuous improvement of all GMP documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
• Stay current regarding industry standards and ensure that all GMP documents are cutting edge and incorporate all latest regulatory and quality requirements.
• Support development and roll out of an electronic batch record.
• Track relevant KPIs.
• Ensure periodic log book reviews are complete.
• Ensure periodic review of all GMP documents are completed on time.

Report regularly to the CEO/CFO, and Audit Committee and Board on compliance matters, regulatory updates, and internal audits

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.

As a quality and compliance expert, you will be responsible for ensuring that Gx.P systems and processes adhere to the applicable regulatory requirements throughout the entire system lifecycle.

Je adviseert klanten en andere partners bij regulatory vragen;.Je doet de opmaak van veiligheidsinformatiebladen en etikettering en de nodige aanpassingen voor de diverse producten zodat ze voldoen aan alle wettelijke vereisten wereldwijd, inclusief ADR , GHS en CLP normen;