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Jobs at Lundbeck (Now Hiring) — 28 open

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Director US Regulatory Global Strategic Labelling

Deerfield, Illinois, United States · Remote OK

$220k–$250k/yr

Senior+$564M raised

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…

Skills: Regulatory Affairs, Global Strategic Labelling, Labeling Compliance, Cross-functional Leadership, Target Product Labelling

Lundbeck logoLundbeck

Maternity cover: Technician / Research assistant, Antibody Engineering, 12-month fixed term contract

Copenhagen, Capital Region of Denmark, Denmark · On-site

Mid level$564M raised

Maternity cover: Technician / Research assistant, Antibody Engineering – 12-month fixed term contract Are you interested in protein expression in mammalian cells and eager to apply your skills to advance innovative treat…

Skills: Mammalian Cell Culture, Protein Expression, HEK293, CHO Cells, Transient Transfection

Lundbeck logoLundbeck

Medical Affairs Scientific Communications Director - Movement Disorders

Deerfield, Illinois, United States · Remote OK

$260k–$290k/yr

Senior$564M raised

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…

Skills: Scientific Communications, Publication Planning, Congress Strategy, Medical Affairs Strategy, Promotional Medical Review

Lundbeck logoLundbeck

Medical Affairs Scientific Communications Director - Movement Disorders

Deerfield, Illinois, United States · Remote OK

$260k–$290k/yr

Senior$564M raised

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…

Skills: Scientific Communications, Publication Planning, Congress Strategy, Medical Affairs, Rare Disease Expertise

Lundbeck logoLundbeck

Supply Chain Student Assistant - Partner Markets

Copenhagen, Capital Region of Denmark, Denmark · On-site

Entry level$564M raised

Supply Chain Student Assistant – Partner Markets Are you an ambitious student eager to gain hands-on experience in supply chain within a global pharmaceutical company? Lundbeck is looking for a talented Intern to join ou…

Skills: Order Management, Data Analysis, Reporting, Process Optimization, Performance Management

Lundbeck logoLundbeck

Safety Scientist, Global Medical Safety Neuro-rare

Copenhagen, Capital Region of Denmark, Denmark · Hybrid

$582k–$800k/yr

Mid level$564M raised

Safety Scientist, Global Medical Safety Neuro-rare Are you passionate about making a difference in the lives of people living with brain disorders? At Lundbeck, we’re driven by a clear purpose: to improve brain health. A…

Skills: Pharmacovigilance, Clinical Development, Signal Detection, Medical Review, Benefit-Risk Assessment

Lundbeck logoLundbeck

Regional Market Access & Pricing Manager

Copenhagen, Capital Region of Denmark, Denmark · On-site

Senior$564M raised

Regional Market Access & Pricing Manager Are you passionate about improving patient access to innovative medicines across Europe? You could be our next Regional Market Access & Pricing Manager, helping with shape access,…

Skills: Market Access, Pricing Strategy, Health Technology Assessment, Health Economics, Reimbursement Frameworks

Lundbeck logoLundbeck

Global Director, Data, Insights & AI Solutions

Copenhagen, Capital Region of Denmark, Denmark · On-site

$910k–$1252k/yr

Senior+$564M raised

Director, Data, Insights & AI Solutions For the commercially savvy and constantly curious leader looking for emerging opportunities to use data and AI to improve how the business works, this is a unique and high-visibili…

Skills: Commercial Strategy, AI Roadmap Development, Data Analytics, Customer Engagement, Digital Transformation

Lundbeck logoLundbeck

Senior Manager, AI Solutions Lead

Copenhagen, Capital Region of Denmark, Denmark · On-site

$786k–$1081k/yr

Senior$564M raised

AI Solutions Lead For the commercially curious and strong AI product builder motivated by turning emerging opportunities into practical business impact, this is a unique opportunity to help shape how Lundbeck applies AI …

Skills: AI Productization, Digital Transformation, Stakeholder Management, GenAI, Customer Engagement

Lundbeck logoLundbeck

Psychiatry Account Manager - Visalia / Fresno, CA

Visalia, California, United States · On-site

$125k–$150k/yr

Mid level$564M raised

Territory: Visalia / Fresno, CA, CA - Psychiatry Target city for territory is Visalia - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries inclu…

Skills: Pharmaceutical Sales, Account Management, Business Planning, Clinical Knowledge, Customer Development

Lundbeck logoLundbeck

Patient Platform Innovation Manager

Datong City, Shanxi, China · On-site

Senior$564M raised

岗位概述 负责公司偏头痛疾病领域患者生态建设及患者服务平台运营,对患者平台增长、患者参与度及患者服务项目运营结果负责。 通过数字化平台运营及患者支持项目、患者组织合作等协同,建立覆盖患者全病程管理的服务体系,持续提升患者教育水平、治疗依从性及长期疾病管理效果,支持业务战略目标达成。 主要职责 1. 患者平台运营与增长 负责公司患者服务平台的整体运营工作,对平台核心运营指标负责,包括但不限于患者注册量、拉新转化率、活跃用户数、留存率及患者…

Skills: Patient Platform Operation, User Growth Strategy, Patient Journey Design, Data Analysis, Project Management

Lundbeck logoLundbeck

Psychiatry Account Manager - Visalia / Fresno, CA

Visalia, California, United States · On-site

$125k–$150k/yr

Mid level$564M raised

Territory: Visalia / Fresno, CA, CA - Psychiatry Target city for territory is Visalia - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries inclu…

Skills: Pharmaceutical Sales, Account Management, Business Planning, Clinical Knowledge, Customer Development

Lundbeck logoLundbeck

Intern Accounts Receivable & Intercompany

Krakow, Lesser Poland Voivodeship, Poland · Hybrid

Entry level$564M raised

If you are curious about the specifics of various financial processes and you are ready to start professional journey within a global company – that`s great. Currently, we are looking for a person who would join us on an…

Skills: Bank Reconciliation, General Ledger, Intercompany Transactions, Customer Query Resolution, Invoicing

Lundbeck logoLundbeck

Brand Assistant Trainee - Psychiatry Business Unit

Barcelona, Catalonia, Spain · On-site

Entry level$564M raised

Brand Assistant Trainee – Psychiatry Business Unit Are you ready to start your career in pharmaceutical marketing and make a difference for people living with brain disorders? You could be our next Brand Assistant Traine…

Skills: Brand Management, Market Insights, Omnichannel Engagement, Event Planning, Cross-functional Collaboration

Lundbeck logoLundbeck

Senior Manager Data and AI Products

Deerfield, Illinois, United States · Remote OK

$150k–$170k/yr

Senior+$564M raised

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…

Skills: Data Strategy, AI Product Management, SQL, Data Analysis, Project Management

Lundbeck logoLundbeck

Vice President Marketing, Movement Disorders

Deerfield, Illinois, United States · Remote OK

$320k–$370k/yr

Senior+$564M raised

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…

Skills: Commercialization Strategy, Omnichannel Marketing, Launch Readiness, Market Shaping, Lifecycle Planning

Lundbeck logoLundbeck

Senior Director, Rare Epilepsy HCP & Payer Marketing

Deerfield, Illinois, United States · Remote OK

$280k–$315k/yr

Senior+$564M raised

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…

Skills: HCP Marketing, Payer Marketing, Omnichannel Strategy, Commercialization Planning, Launch Readiness

Lundbeck logoLundbeck

Psychiatry Account Manager - Los Angeles Central, CA

Los Angeles County, California, United States · On-site

$125k–$147k/yr

Mid level$564M raised

Territory: Los Angeles Central, CA - Psychiatry Target city for territory is Los Angeles - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries in…

Skills: Pharmaceutical Sales, Account Management, Business Planning, Clinical Knowledge, Customer Development

Lundbeck logoLundbeck

Psychiatry Account Manager - Bakersfield, CA

Shafter, California, United States · On-site

$125k–$147k/yr

Mid level$564M raised

Territory: Bakersfield, CA - Psychiatry Target city for territory is Bakersfield - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: B…

Skills: Pharmaceutical Sales, Account Management, Business Planning, Clinical Knowledge, Customer Development

Lundbeck logoLundbeck

Student Assistant - End-User Services

Copenhagen, Capital Region of Denmark, Denmark · On-site

Entry level$564M raised

Student Assistant for End-User Services - Employee Experience & IT Service Design Are you curious about how technology, people, and services come together to create great workplace experiences? Do you enjoy uncovering in…

Skills: Service Design, UX Research, Data Analysis, Employee Journey Mapping, Visual Storytelling

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Showing 1–20 of 28

Lundbeck logo

Director US Regulatory Global Strategic Labelling

Lundbeck

Deerfield, Illinois, United States • Remote OK

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  • $220k–$250k/yr
  • Full-time
  • bachelor degree, postgraduate degree
  • Flexible Paid Time Off, Medical Insurance, Dental Insurance, Vision Insurance, 401k Company Match, Bonus Target
  • Posted 2d ago
  • ~40 hrs/week
  • Remote in United States

Responsibilities

Lead the end-to-end global strategic labelling process for new and revised labels for pipeline assets and marketed products. Coordinate with cross-functional teams to ensure compliant lifecycle management and alignment with regulatory requirements across US and global markets.

Requirements

Requires a Bachelor's degree in life sciences with over 10 years of pharmaceutical industry experience, including 7+ years in Regulatory Affairs. Must have 5+ years of experience developing labelling for US, EU, or other major markets.

Full 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 

 

SUMMARY: 

 

The Director, US Regulatory Affairs Global Strategic Labelling will lead and oversee the development of end- to- end (e2e) labelling process for development of new and/or revised labels, as well as strategic labelling development for pipeline assets. Will champion the implementation of label as driver process from early development through regulatory approval. The individual will be responsible for Global strategic Labelling (GSL) efforts to harmonize US and global processes for ensuring streamlined e2e labelling development and approval, as well as compliant lifecycle management. The individual will serve as a reviewer for the Lundbeck Product Labelling Committee (LPLC) and related labelling compliance activities and may serve as liaison for cross functional governance bodies, such as Safety Committee/Board and LPLC. Collaborates with cross functional team to support development, revision, maintenance and implementation of labelling, while ensuring global and regional requirements and expectations are achieved in an optimal and compliant manner. 

 

ESSENTIAL FUNCTIONS: 

 

  • Lead development of Global 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, coordinating and collaborating with LPLC Chair/Deputy 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 (TPL), 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, Safety, Clinical and International regulatory). 

 

REQUIRED EDUCATION, EXPERIENCE AND SKILLS: 

 

  • Accredited Bachelor’s Degree in life sciences. 
  • 10+ years of experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years of experience in Regulatory Affairs.
  • 5+ 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 EDUCATION, EXPERIENCE AND SKILLS: 

 

  • Masters 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 to be based in Deerfield, IL Office

 

TRAVEL: 

 

  • Ability to travel up to 20% domestic/ international travel may be required. 
  • Ability to support short-term assignment in US/EU, based on product registration scenario. 
  • 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: $220,000 - $250,000 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.

Related keywords

BiopharmaceuticalNeuroscienceBrain HealthRegulatory AffairsGlobal Strategic LabellingLPLCCCDSEU SmPCUSPICPMCarton and ContainerTPLCMCRegulatory OperationsAdvertising and PromotionPharmacovigilance

About Lundbeck

LinkedInVisit site

Advancing brain health. Transforming lives.

Industry
Pharmaceutical Manufacturing
Company size
5,001-10,000 employees
Founded
1915
Headquarters
Valby, Copenhagen
LinkedIn followers
285,224
Total funding
$564M

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

Offices: H. Lundbeck, Ottiliavej 9, Valby, Copenhagen 2500, DK

Neuroscience researchSchizophreniaPsychosisParkinson's diseaseAlzheimer's diseaseDepressionMental HealthPsychiatryNeurologyBrain Health
View all jobs at Lundbeck

About Lundbeck

LinkedInVisit site

Advancing brain health. Transforming lives.

Industry
Pharmaceutical Manufacturing
Company size
5,001-10,000 employees
Founded
1915
Headquarters
Valby, Copenhagen
LinkedIn followers
285,224
Total funding
$564M

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

Offices: H. Lundbeck, Ottiliavej 9, Valby, Copenhagen 2500, DK

Neuroscience researchSchizophreniaPsychosisParkinson's diseaseAlzheimer's diseaseDepressionMental HealthPsychiatryNeurologyBrain Health
View all jobs at Lundbeck

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