Director US Regulatory Global Strategic Labelling

Director, US Regulatory Affairs – Global Strategic Labelling Location: Deerfield, IL, US Remote Opportunity – open to candidates in the greater United States SUMMARY The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end‑to‑end labelling process for new and/or revised labels, as well as strategic labelling development for pipeline assets. The role champions the implementation of label as a driver process from early development through regulatory approval and is responsible for harmonizing US and global processes for streamlined e2e labelling development and approval, ensuring compliant lifecycle management. They serve as reviewer/Deputy Chair for the Lundbeck Product Labelling Committee (LPLC) and other labeling compliance activities, and may serve as liaison for cross‑functional governance bodies. ESSENTIAL FUNCTIONS Lead development of labelling strategy for new products and/or label revisions for existing active marketed products, collaborating with cross‑functional teams during clinical development, regulatory submission and launch. Support Lundbeck Product Labeling Committee activities as LPLC reviewer/Deputy Chair, coordinating with LPLC Chair, GSL Team and cross‑functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance. Provide competitive labeling intelligence and insights to communicate initial labeling frameworks and regulatory expertise to address labeling challenges during development and post‑approval maintenance of global labelling activities. Partner with cross‑functional teams to author and develop competitive and optimal target product labelling, CCDS, EU SmPC, USPI, CPM, Carton and Container and other labeling materials required for marketing registration that aligns with organizational business strategy and regulatory requirements. Ensure effective planning and execution of all cross‑functional labeling activities to maximize timely, high‑quality deliverables. Implement and manage compliance of the Company Core Data Sheet in conjunction with Global Strategic Labelling team and cross‑functional support. Liaise with cross‑functional teams to support labeling‑related information requests from regulatory bodies regarding label content and labeling change requests. Provide high‑level RA advice and identify regulatory requirements for labeling development and compliance, proactively advising on risk‑mitigation strategies for labeling submissions. Assess supporting information to support label language against regulatory requirements. Maintain awareness of global regulatory legislation and assess impact on active marketed, established marketed and development products/programs. Train, develop, and manage an effective regulatory affairs cross‑functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising & Promotion, International regulatory). REQUIRED EDUCATION, EXPERIENCE AND SKILLS Accredited Bachelor's Degree. 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in Regulatory Affairs. 3+ years of experience developing and maintaining labeling for US, EU, and/or major market. Ability to lead and work in cross‑functional, matrixed, hybrid and multinational teams. Demonstrated team leadership and motivation of staff to successfully execute global labeling regulatory strategies. Knowledge of development and registration timelines and requirements in major markets, to enable process management and compliance. Agile minded, with experience in global process improvement efforts. Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective. Deep experience in labeling regulations and label development management. Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory labeling and systems problems. Ability to influence division management at all levels to support regulatory compliance needs. Highly proficient in communicating strategic and tactical issues to management. Effectively able to multi‑task within assigned deadlines. Excellent written and oral communication skills. PREFERRED EDUCATION, EXPERIENCE AND SKILLS Accredited Bachelor's Degree in life sciences. Master's in a science related field. Doctorate Degree or MBA, other professional certifications. Global Regulatory Affairs Experience. Exposure to international regulatory affairs, including participation in submissions to ex‑US authorities. Strong preference for candidate based in Deerfield, IL office. TRAVEL Ability to travel up to 20% domestic/international travel may be required. Ability to support short‑term assignment in US/EU, based on product registration scenario. If based remotely, additional travel will be required to Deerfield, IL to meet the needs of the role and the business. Salary Pay Range: $200,500 - $245,000. Eligible for 25% bonus target based on company and individual performance, and eligible to participate in the company's long‑term incentive plan. Benefits include flexible paid time off (PTO), health benefits (Medical, Dental, Vision), and company match 401(k). Additional benefits information can be found on our career site. Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site. Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E‑Verify. #J-18808-Ljbffr