Senior Professional RA CMC

Select how often (in days) to receive an alert: Role Description Are you an experienced regulatory professional with a strong knowledge of global CMC guidelines? Do you thrive in a dynamic environment where your expertise can drive collaboration and support global regulatory initiatives? At LEO Pharma, we are committed to helping people achieve healthy skin through innovative treatments. We invite you to join our Global CMC Regulatory team in Ballerup, Dublin or Gdansk as a Senior Professional RA CMC, where you will shape the global regulatory CMC strategy for a biological drug product. Build the LEO Pharma of tomorrow Join us in creating a future legacy in medical dermatology. 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 medicines. Your Role Your key responsibilities will include: Develop, plan and execute Regulatory CMC Strategies for post-approval changes to a biological drug product as an active member of a multi-disciplinary team. Identify and communicate potential risks associated with strategy scenarios. Facilitate fast approvals of submissions whilst minimising regulatory risks and maximising post-approval flexibility. Provide regulatory leadership on CMC matters in cross-functional teams, using your expertise in CMC and regulatory insight. Support roll out strategies for licenses in additional markets for a drug device combination product. Support EU, US and Rest of World commercial license maintenance activities (e.g. variations, tech transfers, commitments, PQRs etc). Coordinate the preparation and timely submission of submissions and responses to Regulatory Agencies on CMC drug product aspects (relevant M1 and M2; M3 sections). Lead the project management of CMC changes in collaboration with cross-functional stakeholders - manage timelines to ensure timely approvals and ensure development objectives are met. Act as regulatory CMC representative at internal meetings, as well as support at meetings with business partners and Health Authorities for CMC related issues. Work with the Global Regulatory Team (GRT) to implement strategies and the Regulatory Project Plan, ensuring alignment across Global Safety and Regulatory Affairs (GSRA). Oversee the regulatory authoring and review process for CMC dossiers. Assess regulatory impact of Change Control cases for LEO and external sites. Manage Health Authority interactions for assigned products. Communicate effectively to guide and influence within work group / function regarding life‑cycle management processes. Demonstrate strong problem‑solving skills and ability to address and effectively communicate regulatory issues across multiple functions and geographies. Your Qualifications To excel in this role, you will need: A scientific educational background in pharmacy, pharmaceutics, chemical engineering, biopharmaceutics, biomedicine or equivalent. Minimum 5 years’ experience in Regulatory Affairs in either a pharmaceutical or biotech setting. Proficient understanding of the drug development and LCM of products. Profound knowledge of global CMC guidelines (ICH, FDA, EMA etc) and strategic application of same. Must have experience with CMC regulatory documents (M1, M2.3, M3 for MAAs/ BLAs; variations, responses). Excellent communication and interpersonal skills and ability to build strong relationships. Ability to work independently, willingness to voice opinions in the group environment, proactiveness and attention to details. Proficiency in verbal and written English. Your New Team You will join an experienced and highly motivated team of CMC Regulatory Specialists located internationally (Denmark, Ireland & Spain) who are committed to a learning culture and supporting team members in achieving both business goals and personal development goals. Contact and Application Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities. You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest. Beyond the skin Join 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. #J-18808-Ljbffr