Director US Regulatory Strategy - Remote opportunity Job in Illinois (IL), Director Clinical Research Career, Jobs in Lundbeck
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Life Science Career Fair

Director US Regulatory Strategy - Remote opportunity job in Deerfield

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Lundbeck jobs
Illinois (IL), Deerfield
Job Code:  1036882301
Employer:  Lundbeck
Category:  Director Clinical Research

Location
Country:  United States
State:  Illinois (IL)
City:  Deerfield
02/16/2024

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? 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 in the greater United States, preferably East Coast or Midwest

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). Provides direct oversight and coordination for US based strategists. 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, approval, and post-approval activities.
  • Provides high-level RA advice and identifies regulatory requirements for clinical studies and marketing approval in US.
  • Serves as primary regulatory contact for alliance product brands, as assigned, including managing cross-functional and multi-leveled governance and alignment meetings.
  • 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, Promotion Compliance & Scientific Messaging, and International regulatory).
REQUIRED EDUCATION, EXPERIENCE AND SKILLS:
  • Accredited Bachelor's Degree.
  • 10+ years experience within a pharmaceutical, medical device and/or biotech industry, with 7+ years' experience in Regulatory Affairs.
  • Experience with supporting both small molecule and biological products and ensuring regulatory compliance.
  • Regulatory management experience.
  • Demonstrated and successful experience with face to face, hybrid, and/or virtual FDA interactions.
  • 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.
  • Demonstrated record of investigational and marketing application compliant management and approvals.
  • Proven ability to navigate complex compliance and regulatory strategies.
  • 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 cross functional leadership and alliances.
  • Ability to resourcefully direct the development of creative solutions to unusually complicated regulatory and systems problems.
  • Ability to influence regulatory agency management at all levels to support regulatory needs.
  • Highly proficient in communicating strategic and tactical issues to cross functional 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.
  • FDA experience.
  • Exposure to international regulatory affairs, including participation in submissions to ex-US authorities.
TRAVEL:
  • Willingness/Ability to travel up to 20% domestically, and 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: $ 175,000 - $215,000 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. B enefits 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 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 .

About Lundbeck
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. 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. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.

About Lundbeck

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. 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. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options.
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