Senior Principal Regulatory Devices Lead

Field of work: Regulatory & MedicalPosting Date: 25 Nov 2025Application deadline: 07 Dec 2025Location: Ballerup 2750, Denmark, DenmarkContract type: PermanentJob ID: 3971Are you a recognized expert in global regulatory strategies for Drug Device Combination products? Do you thrive in a dynamic environment where your expertise can drive development and successfully guide global regulatory initiatives? LEO Pharma is seeking a Senior Principal Regulatory Devices Lead to shape global regulatory CMC strategy for our development and commercialized Drug Device Combination Products. If you’re excited to drive impactful regulatory strategies that enable successful development and commercialization of Drug Device Combination Products, we’d love to have you on board! At LEO Pharma, we are global leaders in medical dermatology. We have 115 years' experience in bringing innovation to healthcare. And we are eager to do much more. Each year, close to 100 million people have a better day because of our medicine.Your Role As a Senior Principal Regulatory Devices Lead, you will act as the senior regulatory lead for Drug Device Combination Products at LEO Pharma having full regulatory responsibility for the device constituent part of the products. You will define global regulatory strategies, lead cross-functional alignment, and ensure compliance with FDA, EMA, EU MDR, and other applicable global standards.Your Key Responsibilities Will IncludeDevelop, plan and execute global regulatory strategies for Drug Device Combination Products in development and during life-cycle maintenance: ensuring alignment with FDA (21 CFR Parts 3/4/801/820), EMA/EC (EU MDR and Article 117), and relevant ISO standards . Authority engagement: lead and negotiate with FDA (including OCP), EMA/EC, Competent Authorities, and Notified Bodies; secure NB opinions and align on evidence requirements; Translate governance decisions into executable regulatory roadmaps with clear timelines, deliverables, and cross-functional accountability across Development, Technical functions QA, Clinical Operation, and Commercial. Anticipate regulatory risks and opportunities. Develop evidence-based scenarios and mitigations covering design controls, human factors validation, component/supplier changes, and CMC interfaces (extractables/leachable, drug–device compatibility, container closure integrity). Drive the strategy for evidence and data generation assessing the requirements for HF studies, biocompatibility matrices, sterilization validation, packaging/distribution validation, software documentation etc. Lead submission excellence and readiness across CMC for combination products to streamline reviews for global filings IWork with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Regulatory Affairs (GRA) for combination products. Provide regulatory leadership on Drug Device Combination product matters in cross-functional teams, using your expertise in Devices and regulatory insight. Lead device specific labeling strategy and claims discussionEstablish regulatory intelligence initiatives, and policy shaping mechanisms, distilling external guidance into internal recommendations. Engage with Industry bodies to inform and shape policy. Collaborate with internal teams across development, Technical functions , QA, clinical, and commercial to streamline submissions and regulatory compliance. Your QualificationsTo excel in this role, you should bring:A Bachelor’s or Master’s degree in engineering, pharmaceutical sciences, regulatory affairs, or a related field (an advanced degree is preferred). 12+ years of increasing responsibility in global regulatory affairs for Drug Device Combination Products with a proven track record in CMC/technical leadership. Expert knowledge of FDA, EMA/EC, EU MDR and global device/combination product regulations, standards, and pathways; deep familiarity with 21 CFR Parts 3/4/801/820; EMA Article 117 processes; NB opinion workflows. Advanced expertise across device standards and evidence: ISO 13485, ISO 14971, ISO 10993 series, ISO 11135/11137, ISO 11607, IEC 62366, IEC 62304; cybersecurity expectations; UDI/EUDAMED and labeling requirements (EU MDR Annex I GSPRs). Proven leadership of Technical Files/Design Dossiers, PMA/510(k)/De Novo submissions, and integration of combination product requirements into NDA/BLA filings. Strong knowledge of CMC-device interfaces, including extractables/leachables, drug-device compatibility, and packaging/sterilization validations. Exceptional leadership and mentoring skills, with experience in capability building and establishing processes and frameworks for regulatory excellence . Strong communication and collaboration skills within cross functional teams. Skilled in negotiationand engagement with Agencies and Notified Bodies., Proven ability to navigate complex regulatory landscapes, anticipate risks, and influence senior governance decisions. Contact and Application While this position is based in our HQ in Denmark, we are also open to a hybrid work setup across Europe, enabling you to contribute from your location while fostering close collaboration with the global team.You will work with a collaborative and dedicated group of professionals within the Global Regulatory Affairs Strategy (CMC) department. This role involves interacting with executive leadership, product development, QA, clinical, manufacturing, commercial teams, and external regulatory bodies such as the FDA, EMA, Competent Authorities, Notified Bodies, and industry organizations. You’ll be at the center of a dynamic team, driving compliance and innovation across global markets.Beyond the skinJoin LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact. Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet.At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.For certain positions, LEO Pharma might complete a background check conducted by a third party.Report a concern: Whistleblower hotline | LEO Pharma