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Director, Global Regulatory Affairs, Labeling Strategy

Company: LEO Pharma Inc.
Location: Madison
Posted on: September 13, 2020

Job Description:

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 markets

Leverage the optimal label of the product towards patients and prescribers

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 Specialists.

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 equivalent area

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 required

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 shared objectives.

Personal drive, positive attitude and high level of commitment

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.

Perks

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!

EEOC

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.

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 HRUS@leo-pharma.com.

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Keywords: LEO Pharma Inc., Madison , Director, Global Regulatory Affairs, Labeling Strategy, Other , Madison, Wisconsin

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