159 jobs voor regulatory gevonden

JobomschrijvingAs a successful Regulatory Affairs (RA), Quality Assurance (QA) & Pharmacovigilance (PV) Specialist, you will have the following responsibilities: Regulatory Affairs:.Prepare regulatory documentation & registrations dossier for market authorization of Pharma products (cosmetics, food supplements and homeopathic solutions).

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.

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

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.

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..

De Regulatory Affairs Officer werkt mee in het Regulatory Affairs team, bestaande uit 13 personen dat verantwoordelijk is voor de ondersteuning van de global registration activiteiten...

.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..

.Lead the Quality Assurance Labelling teams, ensuring continuous improvement and regulatory compliance..

You will contribute the preparation of audits (internal/external, regulatory inspections).Identify, mitigate and subsequently resolve compliance and quality issues that may affect company development activities and products.

Regulatory:.Mapping of key regulatory obligations for the group, and in particular relating to data & telecom, and track upcoming changes to said regulations.

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

Legal & Regulatory Specialist voor haar klant in Gent..Als.Legal & Regulatory Specialist ben jij dé spil in het waarborgen van juridische en reglementaire naleving binnen de dynamische energiesector ⚡..

Om de groei en de bijhorende bedrijfstransformaties te ondersteunen dient ook het Legal & Compliance Team versterkt te worden.Bent u de Group Legal Counsel Commercial & Regulatory die onze klant nodig heeft?.

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..

Develop strong relationships with private and public sector stakeholders, identifying opportunities for tailored financial solutions to enhance business development..Manage the bank's financial health, focusing on profitability, risk management, and sustainable growth to ensure effective financial oversight..

JobomschrijvingYou work will include advising clients on the regulatory status of food, feed and their ingredients, pre market authorisation procedures, product positioning and compliance with food information requirements, and the interpretation and application of other EU and national regulatory requirements relevant to specific client circumstances.You will work with fellow associates and in house scientists under the guidance of partners from the relevant practice areas of the Brussels and the DC offices..

Key Responsibilities

• Oversee accurate and timely month-end and year-end closing processes.
• Prepare general ledger journal entries, including accruals, prepayments, and provisions.
• Perform balance sheet reconciliations and ensure compliance with company policies and regulatory frameworks.
• Manage fixed asset accounting, ensuring proper recognition, depreciation, and disposals.
• Prepare, reconcile, and submit all statutory, regulatory, and compliance obligations while addressing queries from auditors and authorities.
• Monitor updates to local statutory and regulatory frameworks, adapting accounting processes as necessary.
• Collaborate with local managing partners and service teams to support budgeting, forecasting, variance analysis, and ad hoc financial analyses.
• Participate in finance projects, including ERP system optimization, and advocate for continuous improvement initiatives.

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.

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.

This role involves conducting comprehensive cybersecurity assessments during the M&A lifecycle, identifying risks, and ensuring alignment with regulatory, legal, and compliance requirements.The ideal candidate will have hands on expertise in cloud security, governance, risk management, and post merger integration strategies.

Reporting to the Chief Medical Officer (CMO), the Medical Director (MD) will lead clinical development activities for new drug candidatesacross multiple therapeutic areas and indications.The MD will assume a hands-on role in the design and oversight of clinical trials, in close partnership Clinical Strategy and Operations, Regulatory Affairs, Pharmacovigilance, and Clinical Research Organizations (CROs).

This role involves conducting comprehensive cybersecurity assessments during the M&A lifecycle, identifying risks, and ensuring alignment with regulatory, legal, and compliance requirements.The ideal candidate will have hands on expertise in cloud security, governance, risk management, and post merger integration strategies.

Ensuring the company's compliance with all regulatory norms within the industry..Creating and managing effective action plans in response to audit discoveries and compliance violations..

Support the team in the creation and implementation of client acquisition strategies.Ensure compliance with all regulatory requirements and company policies.

Our client is a technology consulting company expanding into Belgium to empower businesses with digital transformation and advanced data-driven solutions.They are looking for an experienced Data Analyst with expertise in GDPR, Privacy.

Regulatory Analysis and Compliance

• Ensure compliance with GDPR and other data protection regulations.
• Conduct audits of data management processes to identify gaps in legal requirements.
• Collaborate with legal and compliance teams to document and validate data processing practices.

Data Policies and Process Management

• Design and implement data protection policies (governance, storage, and deletion).
• Define and oversee processes related to individual rights requests (access, deletion, portability, rectification).
• Implement mechanisms for handling data breaches and prepare response plans in case of incidents

Documentation and Traceability

• Maintain up-to-date records of data processing activities.
• Prepare necessary documentation for Privacy Impact Assessments (PIA/DPIA).

• Ensure traceability and documentation of processes to meet audit or regulatory requirements.

   

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

Voor een internationaal farmaceutisch bedrijf in Puurs zoeken wij een Global Regulatory Affairs Specialist.CMC.

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.