Director, US Regulatory Lead

Field of work:  Regulatory & Medical
Posting Date:  18 May 2024

Application deadline:  
Location: MADISON 07940, , United States 
Contract type: Permanent 
Job ID: 2145 

 

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Role Description

Overall Objective: 

Create and drive the regional regulatory strategy for a product / project and ensure there is a sound regulatory foundation for the successful optimization of the product/ project in accordance with business priorities working closely with local RA and/or regional cross-functional stakeholders (e.g., medical affairs, marketing, market access) where required to ensure alignment on gloabl strategy via the GRT.

 

Responsibilities: 

  • Primary Regulatory Affairs representative and responsible to region US in relation to overall project strategy for early and/or late-stage development projects including pre-clinical and clinical.  

  • Responsible for the regional regulatory strategy 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 Global Regulatory Team (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, NDAs/BLAs) for US, working in a global collaborative manner. Ensure timely follow up and execution according to agreed timelines.

  • Maintain expert knowledge of regional and ICH guidance and familiarity with FDA regulations including Competitor intelligence/landscape.

  • Provide clear and valid regulatory guidance, interpretation by applying ‘out of the box thinking’ mind set, direction to GRT, GAT (Global Asset Team)/LCM (Life Cycle Management) teams (as relevant) for 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.

 

Liaison/ Interdependencies:

  • Senior GRL/GRL

  • Members of GRT

  • Local RA (including Ad Promo)

  • Relevant R&D function and EU commercial function

  •  

    Global QA, GPS

  • Local Health Authorities (depending on regulatory procedure local RA should be involved)

 

Requirements: 

  • Master or bachelor’s 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 needed Health Authority interactions/filings/label.  

  • Expert regional regulatory guideline, requirements, and precedence to inform strategic regional considerations. 

  • Regional business acumen.

Behavioral Competencies:

  • 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 gloabally 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.