Head of Regulatory Affairs

The Head of Regulatory Affairs – North America ensures that the Regulatory Affairs team efficiently supports the innovation and growth agenda of the Chronic Care, Wound & Skin Care and Voice & Respiratory Care business areas for the region North America, by providing global strategic and operational leadership to ensure that new products are brought to market on time, sustained throughout the lifecycle and marketed in accordance with applicable regulations.

Major areas of accountability

• Lead and manage a Regulatory Affairs team ensuring domestic regulatory compliance for importing, marketing, promoting and distributing products from the assigned business areas within the region North America.
• Ensure that country-specific regulatory strategies are established and executed in terms of regulatory submission/filing and product/establishment licensing for new product introductions, maintenance of regulatory approvals and product changes, in collaboration with global Regulatory Affairs teams.
• Ensure regulatory compliance and effective implementation of applicable quality requirements in terms for products distribution, labelling and post-market surveillance, in alignment with global processes and local jurisdiction.
• Define and implement the regulatory priorities within the team in alignment with the organization’s objectives.
• Enforce a diverse and inclusive culture of regulatory compliance to boost engagement by recruiting and growing talents and supporting team members to find solutions to critical tasks and obstacles.
• Organize the team and workflow for efficiency by developing competencies and capacity, managing budget, leveraging use of regulatory systems and processes, and developing best practices across the broader Regulatory Affairs function.
• Act as domain expert and influential resource within Coloplast and externally to stay abreast of emerging regulatory intelligence, provide early regulatory guidance during strategy development and represent Coloplast during interactions with regulatory bodies.
• Represent function within relevant leadership forums for the business area by providing critical input on regulatory risks and opportunities for decision-making and enabling strong cross-functional partnerships with key stakeholders through transparent and clear communication and focus on collaborative work and solutions.
• Draw up and sign applicable declarations of conformity and other relevant regulatory statements engaging Coloplast and affiliates on matters relevant to regulatory compliance.
• Other duties as assigned.

Key objectives/deliverables

• Drive timely execution of the regulatory activities for the geographic area by proactively ensuring end-to-end compliance and competitiveness of regulatory strategies, deliverables and submissions/filing per best practices.
• Develop the team, improve processes and organize the daily flow for value-adding and fit for the future.
• Organize the team and ways of working for operational excellence, agility and scalability.
• Nurture an engaging culture of regulatory compliance to promote the company brand on the regulatory scene.

Basic qualifications

• Minimum Bachelor’s degree.
• Minimum 5 years of relevant experience.

Preferred qualifications

• Master of Science degree in regulatory science, life science, biomedical engineering, or other relevant scientific or legal field.
• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS) or other relevant certification in regulatory affairs.
• 2 years of prior managerial experience.

Required knowledge, skills & abilities

• Cross-functional: business & value chain understanding, self-management, decision-making and critical thinking, collaboration & communication.
• Functional competencies: quality management system and processes, regulations, standards and sustainability, design control & validation.
• Leadership: promote the Coloplast Leadership Promise and department’s ambition.