Lundbeck · 2 weeks ago
Director US Regulatory Strategy
Deerfield, IL
Full-time
Hybrid
Director/Executive
$200K/yr - $235K/yr
10+ years expLundbeck is a global biopharmaceutical company focusing exclusively on brain health. 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, providing oversight and coordination for US based strategists and directing a cross functional team.
Health CareHealth DiagnosticsMedical
Responsibilities
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)
Qualification
Required
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
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
Benefits
Flexible paid time off (PTO)
Health benefits to include Medical, Dental and Vision
Company match 401k
Company
Lundbeck
Lundbeck is a pharmaceutical company that develops products to treat people with psychiatric and neurological disorders.
5001-10000 employees
Funding
Current Stage
Public CompanyTotal Funding
$566.37MKey Investors
Michael J. Fox Foundation
2025-05-22Post Ipo Debt· $566.37M
2020-03-04Grant
1999-06-18IPO
Leadership Team
Maria Alfaiate
Executive Vice President Commercialisation and Corporate Strategy
Torben Frandsen
Vice President
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2025-12-08
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