Director US Regulatory Strategy

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 aspectspertaining todrug development,approval, and post-approvalactivities.
  
  

• Provideshigh-level RA advice andidentifiesregulatory requirements for clinical studies and marketing approval inUS.
  
  

• Serves asprimary regulatory contact for alliance product brands, as assigned, includingmanaging cross-functional and multi-leveledgovernance and alignment meetings.
  
  

• Assesses scientific data for registrationpurposedagainst regulatory requirements.
  
  

• Maintains awareness of global regulatory legislation andassessits 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,PromotionCompliance & Scientific Messaging,andInternational regulatory).
  
  

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

• Accredited bachelor's degree
  
  

• 10+ years R&D experience within a pharmaceutical and/or biotech industry, with7+ years' experience in Regulatory Affairs
  
  

• Experience withsupporting bothsmall moleculeandbiologicalproducts and ensuringregulatorycompliance
  
  

• Regulatory management experience (direct or indirect)
  
  

• Demonstratedand successfulexperience withface to face, hybrid, and/orvirtual FDAinteractions.
  
  

• Ability to lead and work in cross-functional, matrixed, hybridand multinational teams.
  
  

• Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
  
  

• Demonstrated record of investigational and marketingapplicationcompliant management andapprovals.
  
  

• Proven ability to navigate complexcompliance and regulatory strategies.
  
  

• Seeker of innovative and creative solutions thatcomply withregulation but are also sound from a business and scientific perspective.
  
  

• Provider ofcontingencies and alternate approaches tocross functional leadershipand alliances.
  
  

• Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems.
  
  

• Ability to influenceregulatory agencymanagement at all levels to support regulatory needs.
  
  

• Highly proficient in communicating strategic and tactical issues tocross functionalmanagement.
  
  

• Effectively able to multi-task within assigned deadlines.
  
  

• Excellent written and oral communication skills
  
  

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

• AccreditedBachelor's Degreein life sciences
  
  

• Masters. Doctorate Degree or MBA, other professional certifications.
  
  

• FDAexperience
  
  

• 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 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 .

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.

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.