Director US Regulatory Strategy

Lundbeck A/S, H; Deerfield (IL); On-site; USD 200,000 - 235,000; Full time

Benefits offered by this job

Bonus target 25%

Medical, Dental & Vision

401k with company match

Flexible PTO

Job summary

Lundbeck seeks a Director, US Regulatory Affairs Strategy to oversee regulatory plans for US and global products. You will lead a cross-functional team, coordinate FDA interactions, and drive registrations from development through post-approval, ensuring compliance and strategic alignment.

Ideal candidates have 10+ years in pharma/biotech R&D with 7+ years in Regulatory Affairs, and prefer Deerfield, IL base with travel up to 20% domestically and possibly internationally.

Qualifications

• 10+ years R&D experience in pharma/biotech with 7+ years in Regulatory Affairs.
• Experience with small molecule and biologics regulatory programs.
• Proven leadership in cross-functional, matrixed teams.
• Experience with FDA interactions (face-to-face, hybrid, and/or virtual).
• Ability to navigate complex regulatory strategies.

Responsibilities

• Lead US product registrations, guiding cross-functional development teams.
• Prepare documentation for Investigational and Marketing applications for the US FDA.
• Liaise with FDA on drug development, approval, and post-approval activities.
• Provide high-level RA advice and identify US regulatory requirements.
• Train and manage a cross-functional regulatory affairs team.
• Monitor global regulatory changes and impact on product development.

Skills

Regulatory strategy

Cross-functional leadership

FDA interactions

Regulatory affairs oversight

Team leadership

Regulatory documentation

Strategic communication

Multi-national teams

Education

Bachelor’s Degree in life sciences

Master’s Degree or MBA

Doctorate Degree

Professional certifications

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 forUS basedstrategists. Directs a cross functional team to ensure that regional requirements and expectations are achieved inan optimaland 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:

• 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 berequired.
• 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 ourcareer site . Applications accepted on an ongoing basis. #LI-LM1

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 .

About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.