Director, US Regulatory Lead

Application deadline:
Location: Madison 07940, New Jersey, United States
Contract type: Permanent
Job ID: 4347


Role Description

Help shape the future of dermatology by driving regulatory strategy for LEO Pharma's most exciting early-stage innovations.
If you thrive in a highly collaborative environment, enjoy thinking creatively within regulatory frameworks, and want to influence programs from the earliest stages of development, this is your opportunity to make a meaningful impact.


Your Role:

In this role, you will create and drive the US regulatory strategy for early stage assets, ensuring there is a sound regulatory foundation for the successful optimization of the product or project in accordance with business priorities. Work closely with cross-functional stakeholders (e.g., clinical development, commercial) to ensure alignment on global strategy via the GRT.


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


Your Responsibilities:

• Serve as the primary U.S. Regulatory Affairs representative for assigned early-stage assets, responsible for all U.S. regulatory activities.

• Develop U.S. regulatory strategy across preclinical and clinical phases in close collaboration with the Global Regulatory Lead.

• Manage the coordinated preparation and timely submission and approval of regulatory filings (e.g., INDs, NDAs, BLAs), including development of briefing packages, team readiness and alignment, and leadership of Health Authority (FDA) interactions.

• Provide regulatory assessment and guidance during due diligence for early-stage Business Development opportunities.

• Maintain expert knowledge of US regulatory requirements 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 teams (as relevant) for the US.

• Act pro-actively and sustain a good stakeholder collaboration within GSRA and in LEO organization via continuous stakeholder management.

Your Qualifications:

• Master's degree or higher in a 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, EoP2, pre NDA/pre BLA)

• Experience in early-stage development is required.

• Broad business understanding and knowing the business and the impact of the project.

• Advanced understanding of the entire drug development process, including how the development program drives required Health Authority interactions, filings, and labeling.

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

You're someone who thrives in a dynamic, collaborative environment-curious, proactive, and solution-oriented, with the confidence to navigate ambiguity and the drive to push projects forward. You balance strategic thinking with a hands-on mindset, communicate clearly across teams, and bring a positive, team-first attitude to every challenge.


Your New Team:

You'll partner closely with the Global Regulatory Lead and GRT members, collaborate with the GPT, and work alongside U.S. Regulatory Affairs (including Ad Promo), R&D, Medical, and Commercial teams. You'll also engage directly with the FDA as you drive regulatory strategy for early-stage assets.


Compensation:

The base salary range for this position is $215,000 - $240,000 per year. The base salary range represents the anticipated low and high of the LEO Pharma range for this position. Salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role. In addition, some positions may include eligibility to earn commissions/bonus based on company and / or individual performance.


Let's pioneer together!

At LEO Pharma, we help people with skin diseases live fulfilling lives by advancing dermatology beyond the skin. We drive dermatology with our knowledge, collaboration, and curiosity, and we are at the forefront of science in developing new medicines. For us, pioneering together is about constantly improving and extending what's possible for each other, our company, and our patients.


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.


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