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Director US Regulatory Strategy - Remote Opportunity

 
Requisition ID:  2389
Location: 

Deerfield, Illinois, US

Date:  Nov 19, 2021
 

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!

 

This is a remote position:  Open to candidates anywhere in greater United States

 

SUMMARY:

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).  Directs a cross functional team to ensure that regional requirements and expectations are achieved in an optimal and 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 aspects pertaining to drug development and approval.
  • Provides high-level RA advice and identify regulatory requirements for clinical studies and marketing approval in US.
  • 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 and Advertising and Promotion, International regulatory).

 

REQUIRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Bachelor’s Degree 
  • 10+ years R&D experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years’ experience in Regulatory Affairs
  • Ability to lead and work in cross-functional, matrixed and multinational teams.
  • Demonstrated team leadership and motivation of staff to successfully execute regulatory strategies.
  • Demonstrated record of investigational and marketing application approvals.
  • 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 Sr. Management and alliances.
  • 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 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
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

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

 

TRAVEL:

  • Willingness/Ability to travel up to 20% domestically. International travel may be required.

 

The range displayed is specifically for those potential hires who will work or reside in the states of Colorado and Connecticut, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $180,000 - $220,000 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.

#LI-LM1, #LI-Remote

 

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

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.

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best. 

Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.  

We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion). 

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.