Lundbeck · 2 weeks ago
Director US Regulatory Global Strategic Labelling
Deerfield, IL
Full-time
Hybrid
Director/Executive
$205K/yr - $245K/yr
10+ years expLundbeck is a global biopharmaceutical company dedicated to brain health, seeking a Director of US Regulatory Affairs Global Strategic Labelling. The role involves leading the labelling process for new and revised products, ensuring compliance and collaboration across teams to support regulatory submissions and product launches.
Health CareHealth DiagnosticsMedical
Hiring Manager
Laurie Meninno
Responsibilities
Lead development of labelling strategy for new products and/or label revisions for existing active marketed products, by collaborating with cross functional teams during clinical development, regulatory submission and launch
Supports Lundbeck Product Labeling Committee activities as LPLC reviewer/Deputy Chair, coordinating and collaborating with LPLC Chair, GSL Team and cross functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance
Provides 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, ensuring cross functional communication and execution per process
Partners with cross functional teams providing labeling expertise and regulatory knowledge to author and develop competitive and optimal target product labelling, CCDS, EU SmPC, USPI, CPM, Carton and Container and other labelling materials required for marketing registration that aligns with Organizational business strategy and regulatory requirements
Ensures effective planning and execution of all cross-functional labeling activities to maximize timebound high quality deliverables
Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support
Liaises with CFTs to support labeling related Information requests from Regulatory bodies regarding label content and labeling change requests
Provides high-level RA advice and identifies regulatory requirements for labeling development and compliance to proactively advise on risk mitigation strategies for labeling submissions
Assesses supporting information to support label language against regulatory requirements
Maintains awareness of global regulatory legislation and assesses impact to active marketed, established marketed and development products/programs
Trains, develops, and manages an effective regulatory affairs cross-functional team on key labelling requirements (CMC, Regulatory Operations, US Labeling and Advertising and Promotion, International regulatory)
Qualification
Required
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 labelling 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 labelling 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
Accredited Bachelor's Degree in life sciences
Master's in 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 to 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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