Compliance

• Contributing to the late-stage development strategy for one of Novo Nordisk's key assets within the obesity and cardiometabolic health therapy area
• Developing and planning the global marketing authorisation submission strategy for a highly complex development programme pursuing multiple indications
• Driving innovative and fit-for-purpose submission strategies, including exploring new ways of structuring and executing submissions to support complexity, speed, and quality
• Leading and guiding the regulatory submission team and cross-functional stakeholders to ensure aligned execution, strong decision-making, and timely delivery of submission activities
• Working across development projects in combination with life cycle management activities, ensuring a coherent and forward-looking regulatory strategy

Regulatory Affairs Specialist

• Lead the Compliance team
• Manage and develop Danske Commodities’ compliance programme
• Stay on top of regulatory developments and business ethics requirements
• Translate knowledge into clear compliance programmes for company activities
• Drive strong compliance culture through close cooperation with stakeholders
• Review, implement and communicate policies, guidelines and procedures
• Execute compliance training for trading teams and relevant employees

Compliance Officer

• Coordinate and lead the execution of global regulatory strategies for complex development projects
• Prepare and contribute to Clinical Trial Applications worldwide
• Coordinate the submission of initial Marketing Authorization Applications
• Provide regulatory expertise to cross-functional project teams
• Build strong partnerships across the organization
• Ensure high-quality regulatory deliverables throughout the product development lifecycle

Regulatory Specialist

• ISB-administration og mødeforberedelse
• Assistance ved ISAE-revision
• Bidrage til GDPR-relateret dokumentation
• Udbrede kendskabet til sikkerhedspolitikker internt
• Samarbejde på tværs af afdelinger

Compliance Coordinator – Student Assistant

• 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

Compliance jobs in Denmark

See all jobs on JobTailor