Compliance

• Create, maintain, and improve the technology compliance framework
• Monitor compliance against the framework
• Use audits, reviews, findings, and stakeholder feedback to strengthen the framework
• Build strong relationships across the business

Technology Compliance Manager

• Support selected projects and products in the Novo Nordisk portfolio
• Provide strategic and scientific input to support development
• Secure regulatory approvals, and ensure compliance with evolving global regulations
• Lead and drive strategic regulatory device activities for drug-device combination products
• Plan, prepare, and lead health authority interactions and meetings
• Identify regulatory risks and opportunities, and provide clear recommendations

Regulatory Affairs Specialist – Device

• Be accountable for and lead end-to-end regulatory submission activities for cross-product, cross-site, and manufacturing facility/equipment change projects.
• Contribute to new product submissions by leading regulatory strategies and activities related to manufacturing facilities and equipment.
• Coordinate activities related to the creation and maintenance of dossier documentation for manufacturing facilities, manufacturing equipment, and associated processes (such as cleaning validation, sterilisation, environmental monitoring, media-fill etc).
• Demonstrate strong leadership by setting the strategic regulatory direction for projects.
• Acting as an RA Site Partner by fostering close collaboration with manufacturing sites to proactively align on planned site-level changes.

Regulatory Affairs Specialist – RA Manufacturing Facilities, Projects

• Coordinate tasks across multiple functions and act as a central link for HSE and ISO compliance activities.
• Maintain the internal HSE & ISO Compliance SharePoint page and ensure operational model availability for stakeholders.
• Carry out invoice control and administrative follow-up.
• Prepare training materials, guides, internal communications, and newsletters.
• Support structure and progress in Opt in activities for various certifications.

Compliance Coordinator

• Ensure evaluation, prioritisation, implementation, communication, and training in new Veeva RIM features across Regulatory Affairs
• Support and drive Veeva RIM process development and optimisation
• Engage with stakeholders and external vendors, providing technical guidance and regulatory input to ensure fit-for-purpose processes and solutions
• Guarantee alignment with external regulatory requirements

Regulatory Professional – Veeva RIM

Regulatory Professional

• Support selected products in the Novo Nordisk portfolio, focusing on late-stage development and life-cycle management submissions across global markets
• Lead and drive strategic regulatory CMC activities to ensure timely approvals and compliance
• Translate pharmaceutical operations knowledge into robust global regulatory CMC strategies
• Apply CMC regulatory intelligence to strengthen submissions and regulatory pathways
• Plan, coordinate and review regulatory documentation, including submission modules and responses to health authority questions
• Contribute to continuous improvement of regulatory CMC practices, processes and documentation

Regulatory Affairs CMC Specialist

• Develop and manage cyber security compliance activities in global offshore windfarm operations
• Ensure compliance with international and national cybersecurity regulations and standards
• Act as a technically oriented compliance expert
• Support continuous compliance of OT operations in critical infrastructure environments
• Contribute to information security management processes
• Lead compliance and audit activities on a global level
• Collaborate with and support Regional Cyber Security Officers
• Manage compliance baseline documentation system and related artifacts
• Develop methodologies and tooling concepts to automate compliance management
• Establish cybersecurity frameworks, policies, and procedures for offshore wind farm environments
• Perform control assessments and risk assessments from the compliance perspective
• Maintain and facilitate internal and certification audits and governmental inspection activities
• Coordinate and support local compliance activities of Regional Cyber Security Officers

OT Compliance Manager

• Monitor EU and international legislation and standardization activities relevant to Nilfisk products and technologies, including Ecodesign, Energy Labelling, Machinery Regulation, and sustainability‑related legislation
• Collect regulatory and standardization intelligence through trade organizations, industry forums, standardization bodies, and public consultations
• Proactively assess relevance and business impact of external developments by coordinating with internal stakeholders across PCS, Technology R&D, Product Lines, and ESG
• Provide structured regulatory horizon scanning and periodic updates tailored to Nilfisk priorities and product roadmaps
• Translate regulatory and standardization developments into clear, actionable internal guidance, ensuring internal alignment before external positions are taken
• Represent Nilfisk in selected external working groups and forums where strategic relevance has been identified

Product Regulations Specialist

• Shape the regulatory future of life-saving medicines
• Lead a global organization spanning four departments
• Oversee Chemistry, Manufacturing, and Controls (CMC) regulatory activities
• Ensure compliance while scaling manufacturing processes
• Develop approval strategies for new manufacturing sites
• Collaborate with supply chain and manufacturing teams
• Lead high-performing teams across multiple regions
• Manage negotiations with major regulatory bodies
• Ensure seamless transition as products move to large-scale manufacturing

Senior Director, Regulatory Affairs – CMC and Lifecycle Management

• Coordinating meetings (including global), agendas, minutes, and follow-ups
• Maintaining organisation charts, documentation libraries, and shared mailboxes
• Supporting preparation of presentations, reports, dashboards, and internal communication material
• Providing administrative and coordination support to managers and stakeholders
• Assisting with compliance activities such as access reviews, audits, and evidence collection
• Performing initial quality checks on documentation and maintaining audit logs, risk registers, and tracking sheets
• Following up on actions, owners, and deadlines across the team
• Supporting process documentation, policies, and training materials
• Uploading and distributing training content and supporting training planning and reporting

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