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Director US Regulatory Global Strategic Labelling - Remote Opportunity

Employer
Lundbeck
Location
Working From Home
Start date
Apr 12, 2024

View more

Discipline
Regulatory, Regulatory Affairs
Required Education
Bachelors Degree
Position Type
Full time

Job Details

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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

 

Remote Opportunity - Open to candidates anywhere in the greater United States

 

SUMMARY:
The Director, US Regulatory Affairs Global Strategic Labelling, oversees the process and compliance of the global labelling, including critical implementation of label as driver process and efforts to harmonize US and global processes, to ensure the successful development and approval of product labelling, as well as compliant lifecycle management.  Responsible party for the Lundbeck Product Labelling Committee (LPLC), serving as liaison for cross functional governance bodies, such as Safety Committee/Board and US labeling committee.  Collaborates with cross functional team to support implementation and control of labelling, and directs a cross functional resources to ensure global requirements and expectations are achieved in an optimal and compliant manner.

 

ESSENTIAL FUNCTIONS:

  • Serves as LPLC chair, coordinating and collaborating with Global Strategic Labelling leadership and cross functional partners to ensure adherence to processes and procedures related to global labelling development, maintenance, and compliance. 
  • Provides regulatory expertise for the development and post-approval maintenance of global labelling, ensuring cross functional communication and execution per process.
  • Partners with cross functional team to ensure development of target product labelling, as well as marketing registration labelling materials for the FDA and EMA.
  • Responsible for the implementation and compliance management of the Company Core Data Sheet, in conjunction with Global Strategic Labelling team and cross functional support.
  • Coordinates cross functional support to ensure compliance of global requirements.
  • Liaises with Regulatory bodies regarding label development and change management.
  • Provides high-level RA advice and identify regulatory requirements for labelling development and compliance.
  • Assesses supporting information to support label language against regulatory requirements.
  • Maintains awareness of global regulatory legislation and assess impact to marketed and development 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).

 

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

  • 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 compliance 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 regulatory strategies.
  • Knowledge of development and registration timelines and requirements, 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 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:

  • Accredited Bachelor’s Degree in life sciences
  • Masters. Doctorate Degree or MBA, other professional certifications.
  • CMC Experience
  • Exposure to international regulatory affairs, including participation in submissions to ex-US authorities

 

TRAVEL:

  • Ability to travel up to 20% international travel may be required.

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 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 and is an affirmative action employer. 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.

Company

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

Offices in:

  • Deerfield, IL - Lundbeck US Home Office
  • LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
  • Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc

Diversity

Diversity matters, and inclusion creates powerful organizations

To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset.

Benefits

Lundbeck offers a competitive benefits package that includes:

• Medical, dental, vision effective day 1 of employment

• Generous vacation, sick leave, holiday shut down and company paid holidays

• 401k match with immediate vesting

• Parental Leave

• Hybrid work model for office-based roles

To view more details about our Benefits, please click on the link below.

Lundbeck 2023 Benefits Summary

Sustainable Development Goals

In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:

• Goal 3: Good Health and Well-being

• Goal 5: Gender Equality

• Goal 8: Decent Work and Economic Growth

• Goal 10: Reduced Inequalities

• Goal 12: Responsible Consumption and Production

• Goal 13: Climate Action

• Goal 16: Peace, Justice, and Strong Institutions

Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).

Lundbeck

Who We Are

A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.

What We Strive For

Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.

What Drives Us

A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.

Our Societal Commitment

We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.

Our Investment in You

As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.

Employee Satisfaction

The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.

Employee

Our Beliefs

• Patient-driven We put patients at the center of our fight for health and human dignity.

• Courageous We dare to confront unsolved healthcare challenges.

• Ambitious We set high expectations for ourselves because people in need have high expectations of us.

• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.

• Responsible We act with respect and integrity in everything we do

   

CONNECT

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Company info
Website
Phone
224-507-1000
Location
6 Parkway North
Deerfield
Illinois
60015
US

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