Director, Global Regulatory Affairs, Labeling Strategy Global
Regulatory Affairs Madison, New Jersey
Thank you for your interest in the Director, Global Regulatory
Affairs, Labeling Strategy, opportunity based in Madison, NJ
At LEO Pharma, we seek passionate, entrepreneurial and
solutions-oriented colleagues, and consistently ensure that our
people can proactively develop their capabilities and fulfil 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. With a robust R+D pipeline we have a
strong vision to become the preferred dermatology care partner.
What a Director, Global Regulatory Affairs, Labeling Strategy at
LEO Pharma will fulfill:
The purpose of the role is to create and drive the Global
regulatory labeling strategy for one or several products, ensuring
alignment with the Global regulatory and commercial strategies, as
well as Health Authority requirements and opportunities. This
position will furthermore be expected to act as mentor and ensure
knowledge sharing of strategic labeling intelligence within the
team of Regulatory Labeling Specialists.
Your contribution to the team includes:
Lead and engage relevant stakeholders to ensure the optimal
target product label, company core datasheet and label for
NDAs/BLAs/MAAs, including: Provide strategic labeling input
(opportunities and risks) to development projects
Provide regulatory guidance on the optimal design of the
clinical development program to support the label claims in key
Leverage the optimal label of the product towards patients and
Lead and provide input to scientific and strategic discussions
on relevant labeling activities
Act as a key stakeholder and drive the strategic agenda for
labeling negotiations with regulatory authorities
Train, act as mentor and ensure knowledge sharing of strategic
labeling intelligence within the team of Regulatory Labeling
Maintain expert knowledge of, and familiarity with FDA/EMA/key
international market regulations and ICH labeling guidelines.
Challenge and improve existing procedures.
What you will bring to this role:
10+ years of experience in pharma/biotech in regulatory or
Master’s degree or bachelor within science e.g. pharmaceutics,
biomedicine, chemical engineer or a related field
Strong expert knowledge of strategies to optimize labels during
development and life-cycle management of products is required
Strong expert knowledge of various regulatory environments,
including EU and US, is required
Expert knowledge of science and data relevant for the label is
Expert knowledge of interaction with Health Authorities,
compilation of labeling documentation for EU and US
Strong business acumen
Experience with driving and leading projects
Excellent stakeholder management skills are required.
Collaborating, managing experts and building partnerships to meet
Personal drive, positive attitude and high level of
Excellent written and verbal communication skills
The ability and willingness to travel internationally (mainly
Europe) approximately 20% of working time
Must be able to perform all essential functions of the position,
with or without reasonable accommodation.
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!
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action
Employer committed to an inclusive and diverse workforce that
creates a better future for our global communities. Applicants will
receive consideration for employment without regard to race, color,
religion, sex, sexual orientation, gender identity, age, national
origin, or protected veteran status and will not be discriminated
against on the basis of disability.
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
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 HRUS@leo-pharma.com.
You have been redirected to a LEO Pharma Inc. job page