Director US Regulatory Strategy

Director US Regulatory Strategy Employer Lundbeck Location Deerfield, IL, US Start date Apr 5, 2026 View more categories View less categories Discipline Marketing , Regulatory , Regulatory Affairs Required Education Bachelors Degree Position Type Full time Hotbed BioMidwest , Best Places to Work Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Send job Job Details Company Job Details Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth! Remote/Commuter Opportunity

• Open to candidates within the United States The Director, US Regulatory Affairs Strategy, oversees the implementation of regulatory strategies to ensure the successful development and approval of assigned drug and biological products for the United States (global products as well as US only products).

Provides direct oversight and coordination for US based strategists. Directs a cross functional team to ensure that regional requirements and expectations are achieved in an optimal and compliant manner.

ESSENTIAL FUNCTIONS

Serves as US and/or global product registration leader for US products, influencing cross functional development teams and governance. Oversees assembly and creation of documentation to support investigational and marketing registration packages for the US FDA. Liaises with FDA as needed for all aspects pertaining to drug development, approval, and post-approval activities. Provides high-level RA advice and identifies regulatory requirements for clinical studies and marketing approval in US. Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings. Assesses scientific data for registration purposed against regulatory requirements. Maintains awareness of global regulatory legislation and assess its impact on business and Lundbeck product development programs. Trains, develops, and manages an effective regulatory affairs cross-functional team on a dotted-line basis (CMC, Regulatory Operations, US Labeling, Promotion Compliance & Scientific Messaging, and International regulatory).

REQUIRED EDUCATION, EXPERIENCE AND SKILLS

Accredited bachelor's degree 10+ years R D experience within a pharmaceutical and/or biotech industry, with 7+ years' experience in Regulatory Affairs Experience with supporting both small molecule and biological products and ensuring regulatory compliance Regulatory management experience (direct or indirect) Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions. Ability to lead and work in cross-functional, matrixed, hybrid and multinational teams. Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies. Demonstrated record of investigational and marketing application compliant management and approvals. Proven ability to navigate complex compliance and regulatory strategies. Seeker of innovative and creative solutions that comply with regulation but are also sound from a business and scientific perspective. Provider of contingencies and alternate approaches to cross functional leadership and alliances. Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems. Ability to influence regulatory agency management at all levels to support regulatory needs. Highly proficient in communicating strategic and tactical issues to cross functional 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 Masters. Doctorate Degree or MBA, other professional certifications. FDA experience Exposure to international regulatory affairs, including participation in submissions to ex-US authorities Strong Preference to be based in

Deerfield, IL Office TRAVEL:

Willingness/Ability to travel up to 20% domestically, and international travel may be required. If based remotely, additional travel will be required to Deerfield, IL, to meet the needs of the role and the business The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role.

Salary Pay Range:

$200,000

• $235,000 and eligibility for a 25% bonus target based on company and individual performance, and eligibility to participate in the company's long-term incentive plan.

Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our career site . Applications accepted on an ongoing basis. #LI-LM1, #LI-Remote Why Lundbeck Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. 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 . Company Lundbeck is a global biopharmaceutical company specialized in brain diseases. We are dedicated to advancing brain health and transforming lives. To fulfill this purpose, Lundbeck is engaged in the research, development, manufacturing, and commercialization of pharmaceuticals across the world. For more than 70 years, Lundbeck has been at the forefront of neuroscience research. Our commitment is to empower patients to give them the tools and resources they need to understand their disease and its unfolding. Our commitment is to continuously challenge status quo and push our science further to make real differences for patients. Our commitment is to families to bring evidence-based data, visibility and support to their work in managing a chronic disease. Our commitment is to communities to end the stigma, fear, and silence that surrounds brain diseases. Our commitment is to society, to increase access to medicines for the most vulnerable, to act responsibly towards the environment and to behave with respect and integrity in everything we do.

Offices in:

Deerfield, IL

• Lundbeck US Home Office La Jolla, CA
• Lundbeck La Jolla Research Center, Inc. Bothell, WA
• Lundbeck Seattle BioPharmaceuticals, Inc Company info Website https://www.

lundbeck.com/global Phone 224-507-1000 Location 6 Parkway North Deerfield Illinois 60015 United States Share this job Facebook Twitter LinkedIn Apply now Send job Apply now Save job Click to add the job to your shortlist You need to sign in or create an account to save a job. Get job alerts Create a job alert and receive personalized job recommendations straight to your inbox. Create alert