Director, US Regulatory Lead

Application deadline:  
Location: Madison 07940, New Jersey, United States 
Contract type: Permanent 
Job ID: 3107 

Your Role

You will create and drive the US regulatory strategy for a product / project, ensuring there is a sound regulatory foundation for the successful optimization of the product /project, in accordance with business priorities.  This role will work closely with cross-functional stakeholders (e.g., medical affairs, marketing, market access), ensuring alignment on global strategy via the GRT.

This is a hybrid role, based out of LEO's Madison, NJ office.

Your Responsibilities 

•    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 US regulatory strategy and ensuring alignment with global commercial plans and priorities to optimize portfolio. 
•    Responsible for regulatory interactions, and submissions, with strategic accountability 
•    Manage coordination, preparation and timely submission and approval of various original and variation filings (e.g., INDs/ NDAs/BLAs), 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 GSRA and in LEO organization via continuous stakeholder management.
•    Represent GSRA according to delegated tasks.
•    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.
 

Your Qualifications

•    Master’s or degree within natural science or equivalent.
•    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.
•    Strategic global mindset with a curious and alternative mindset 
•    Proactive thinking and a ‘yes-can-do’ attitude.
•    Team player and effective communicator to secure ‘one GRA voice’. 
•    Effective stakeholder management – anticipating and balancing the needs of multiple stakeholders.
•    Personal drive, positive attitude and high level of commitment
•    Think locally act globally; think globally act locally.

Beyond the skin

Join LEO Pharma, a global leader in medical dermatology, as we go beyond the skin to make a lasting impact.  Our innovative approach sets us apart. We are dedicated to leaving a legacy that positively impacts patients, colleagues, and our planet. 
 
LEO Pharma Inc. is an Equal Opportunity/Affirmative Action Employer. At LEO Pharma, we believe that our different perspectives, backgrounds, and attitudes are what enable us to make the best decisions, foster an inclusive culture, and meet the needs of the market we operate in. Therefore, we encourage you to apply for the position if you are excited about the role – even if you don’t meet every single requirement listed, you might be just the pioneer we are looking for. With this in mind, 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. We believe in flexibility in all aspects - also when it comes to supporting our employees' diverse needs, hence, we offer hybrid work opportunities whenever possible.

For certain positions, LEO Pharma might complete a background check conducted by a third party.

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.
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.