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Director, U.S. Regulatory Affairs Lead, Madison, New Jersey

Created 06/16/2021
Reference oc7Tffwb
Category Global Regulatory Affairs
Job type Full Time
Country United States
State New Jersey
City Madison
Zip Not specified
Salary Competitive

Thank you for your interest in the Director, U.S. Regulatory Lead opportunity based at LEO Pharma U.S. headquarters in Madison, NJ. or remote within in the Eastern U.S. time zone.

At LEO Pharma, we seek passionate, entrepreneurial and solutions-oriented colleagues, and consistently ensure that our people can proactively develop their capabilities and fulfill their potential. Together, we can embrace the changing healthcare landscape and grasp strategic business opportunities. The result: life-enhancing products that bring hope to patients living with chronic dermatologic diseases.

About the Director, U.S. Regulatory Lead:
The Director, U.S. Regulatory Lead is responsible for creating and driving the regional regulatory strategy for a product / project and ensure sthere is a sound regulatory foundation for the successful optimization of the product /project in accordance with business priorities, while working closely with local RA and/or regional cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on global strategy via the Global Regulatory Team.

Your contribution to the team includes:
  • Primary RA representative and responsible to their region in relation to overall project strategy including pre-clinical and clinical (working with local RA where required).
  • Responsible for the regional regulatory strategy by liaising with local RA to ensure alignment with regional and global commercial plans and priorities to optimize portfolio.
  • Responsible for regulatory interactions, and submissions, with strategic accountability for the regional filings while leveraging their GRT subject matter experts and endorsed by GRT.
  • Review relevant documents that will be included in regional /global regulatory applications/interactions in accordance with local and global regulatory guidance / legislation, as applicable, while leveraging GRT subject matter expertise.
  • Manage coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/CTAs, MAAs, NDAs/BLAs) for their region, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines.
  • Maintain expert knowledge of region and ICH guidance and familiarity with FDA/EMA/key international market regulations including Competitor intelligence/landscape.
  • Provide clear and valid regulatory guidance, interpretation by applying 'out of the box thinking' mind set, direction to GRT, GPT/LCM teams (as relevant) and region of responsibility.
  • Act pro-actively and sustain a good stakeholder collaboration within GRA and in LEO organization via continuous stakeholder management.
  • Represent GRA according to delegated tasks.
  • Provide budget input for regions plans.

Required Experience:
  • Master's degree within natural science or equivalent.
  • 5+ years' seniority within regulatory 5+ years, with primary responsibility of having achieved major local regulatory milestones, including drug development milestones (e.g., pre-IND, National Advice) and/or life cycle management milestones (e.g., line extensions).
  • Broad business understanding and knowing the business and the impact of the project.
  • Advanced understanding of the entire drug development/LCM process and how the development/LCM program and needed Health Authority interactions/filings/label.
  • Understanding of science and data relevant for development and LCM.
  • Expert regional regulatory guideline, requirements and precedence to inform strategic regional considerations.
  • Regional business acumen.

Ready to learn more about LEO Pharma?
LEO Pharma has been pioneering medical innovations for more than 110 years. Today, LEO Pharma looks to constantly improve and extend what is possible for the benefit of patients. Our rapidly expanding product portfolio and pipeline includes global therapeutic areas in psoriasis, eczema, skin infections, acne, rosacea and, most recently, rare disease.

LEO Pharma believes in challenging the status quo, so we approach dermatology "beyond the skin." Our global innovation ecosystem includes internal research and development, digital health via the LEO Innovation Lab, based in Copenhagen, and the LEO Science & Tech Hub, housed in Cambridge, Mass.

As we look to shape our U.S. footprint now and in the future, we pride ourselves on our agile and entrepreneurial environment. It allows passionate people to collaborate and push the boundaries of science in hopes to provide solutions for patients.

We offer a competitive compensation package, 401k match, vision, dental and health insurance, annual bonus, three weeks' vacation to start, a culture that emphasizes work-life balance, both paternity and maternity leave, free membership to the on-site gym, bagel Monday's and - most of all - a FUN and celebratory work environment.

Let's wrap this up
If you are interested in joining a growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!

A diverse workforce fosters innovation and strengthens Leo Pharma's mission. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.

Thank you for your interest in career opportunities at LEO Pharma Inc.

Please note:
LEO Pharma Inc. seeks information for job applications from candidates in the U.S. through only the following channels: the LEO Pharma Inc. website and Halogen Talent Acquisition, powered by Jobvite via email to/from addresses using only the LEO Pharma domain of "@leo-pharma.com" screening and interaction by telephone and through the Microsoft Teams platform.

LEO Pharma does not use Google Hangouts, Zoom or any other platform for any recruitment-related activities.

Disregard any solicitation or request for information related to job applications with LEO Pharma via any other means and/or using email addresses with any other domain.

LEO Pharma will never ask candidates to make any type of personal financial investment related to gaining employment with the company.

If you have any questions about LEO Pharma Inc. and the application process, please email the company's U.S. People and Communications team at [email protected]