Back

Jan 06, 2026

Director US Regulatory Strategy

Lundbeck LLC
Deerfield, IL, USA

Information Technology Sales Neuroscience

Job Description

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.

States

Apply Now

Lundbeck LLC

Lundbeck is a 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.

Brain disorders affect a large part of the world’s population, and the effects are felt throughout society. With the rapidly improving understanding of the biology of the brain, we hold ourselves accountable for advancing brain health by curiously exploring new opportunities for treatments.

As a focused innovator, we strive for our research and development programs to tackle some of the most complex neurological challenges. We develop transformative medicines targeting people for whom there are few or no treatments available, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
We are committed to fighting stigma and we act to improve health equity. We strive to create long term value for our shareholders by making a positive contribution to patients, their families and society as a whole.

Lundbeck has more than 5,000 employees in more than 20 countries and our products are available in more than 80 countries. For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us via LinkedIn.

Offices in:

Deerfield, IL - Lundbeck US Home Office
La Jolla, CA - Lundbeck La Jolla Research Center, Inc.
Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc

We believe that if we build an inclusive, equity-focused organization, diversity will follow.

In simple terms, diversity is the mix. Inclusion is making the mix work. Equity is making sure we are fair and impartial in that process.

Diversity matters, and equity and inclusion create powerful organizations

To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences, but because of them.

We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to DE&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure DE&I is an integrated practice and mindset.

Benefits

Lundbeck offers a competitive benefits package that includes:

Medical, dental, vision effective day 1 of employment
Generous vacation, sick leave, holiday shut down and company paid holidays
401(k) match with immediate vesting
Non-Contributory 401(k) Employer Contribution
Parental Leave
Hybrid work model for office-based roles

To view more details about our Benefits, please go to the webpage below.

https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/Lundbeck_Benefits_Summary.pdf

Our Sustainability Strategy

Through our sustainability strategy, we mitigate business risks, reduce negative impacts, and address societal challenges where possible. We remain committed to UN Global Compact Principles and contribute to seven of the 17 UN Sustainable Development Goals.

Lundbeck became a signatory to the UN Global Compact in 2009. We continue to promote initiatives that demonstrate our commitment to the 10 principles on human and labour rights, environment protection and anti-corruption.

Executive Management assesses Lundbeck’s business risks and opportunities and establishes our sustainability targets as communicated in our annual report.

We release an annual sustainability report describing in detail our sustainability performance and targets. For over a decade, we have reported on our sustainability efforts, challenges and contributions to our business, stakeholders and the societies we operate within.

Who We Are

A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.

What We Strive For

Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.

What Drives Us

A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.

Our Societal Commitment

We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.

Our Investment in You

As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.

Employee Satisfaction

The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.