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Legal Counsel - Regulatory Affairs, Madison, New Jersey

Created 08/26/2021
Reference oMvHgfwY
Category Legal and Compliance
Job type Full Time
Country United States
State New Jersey
City Madison
Zip Not specified
Salary Competitive

This role will assist with all legal activities in the US Region and help prepare the organization to execute on the 2030 strategy, with primary responsibility for providing legal support for the team responsible for pipeline products.

Roles and Responsibilities
  • Counsel and train stakeholders on relevant laws and regulations related to promotional activities, product labeling, and marketing strategies
  • Actively represent Legal perspective regarding Advertising/Promotion in Legal/Medical/Regulatory (LMR) meetings
  • Provide guidance on appropriate pre-launch and launch activities for various LEO Pharma products in any point of the development lifecycle
  • Review and provide legal advice on advertising and promotional materials, training materials, press releases and similar pieces
  • Conduct risk assessment on marketing strategies and communicate to management appropriately and in a timely manner
  • Provide legal advice for LEO Affiliates engaging in activities in the US
  • Assist with internal investigations related to violations of internal policies or the LEO Code of Conduct, as necessary
  • Draft, review, and negotiate contracts, as necessary
  • Maintain awareness of relevant laws and regulations, keeping abreast of current changes that may affect the organization
  • Conduct any necessary due diligence
  • Draft/revise and implement guidance documents
  • Additional duties as assigned by LEO Pharma Management

Complete all company-based and job-related training as assigned by LEO Pharma within the required timeline

Key Working Relationships

This position will interface with various department across the LEO Pharma organization such as Marketing, Regulatory Affairs, Medical Affairs, Value Access & Public Affairs, Sales, Human Resources, and Clinical Operations, Quality Affairs and Communications in the US and globally.

Job Specific Competencies
  • Juris Doctor (JD) and licensed in New Jersey
  • Prior in-house experience with a pharmaceutical, biotechnology or other life sciences company
  • Extensive industry knowledge gained by participation in one or more cross-functional group on issues such as risk evaluation, product recalls, clinical research, compliance matters
  • Prior experience in biologics is preferred
  • Previous experience participating on an advertising and promotional review committee as legal reviewer

Behavioral Competencies
  • Strong focus on stakeholder management; ability to effectively manage ambiguity and identify and mitigate risks
  • Strong team player with ability to manage projects independently
  • Strong strategic drive and focus
  • Excellent communication skills
  • 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, an on-site game room, free membership to the on-site gym, plenty of coffee machines and - most of all - a FUN and celebratory work environment.

Let's wrap this up

If you are interested in joining a small, growing and nimble company, and help shape the future of medical dermatology, then send in your resume today!

At LEO Pharma, we welcome and consider applications from all qualified candidates because we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions for LEO Pharma and meet the needs of the wonderfully diverse marketplace we operate in.

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.

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

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 interactionby telephone and through the Microsoft Teams platform.

Please note:
  • 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] .