Principal Regulatory Toxicologist

Application deadline: 23-March-2025 
Location: Ballerup 2750, Denmark, Denmark 
Contract type: Permanent 
Job ID: 2979 

Are you passionate about toxicology and eager to help getting new products approved? Are you ready to support an established portfolio with your expertise within safety and risk assessment? Are you thrilled about joining LEO Pharma as we embark on a new chapter in our innovation strategy? Are you prepared to join a dynamic team where your expertise will truly make a difference?

Shape the LEO Pharma of tomorrow  

At LEO Pharma, our mission transcends the conventional. We are on an ambitious path to become the leaders in medical dermatology worldwide. If you are ready to make a difference, this role is your gateway to a world of opportunities!

In our department Translational Sciences, we share a “challenge accepted” mindset and are guided by our winning behaviors of simplification, collaboration, and accountability to achieve our goals.

Your new role

As a Regulatory Toxicologist, you will be an integral part of a multidisciplinary team engaged in the toxicological assessment and communication of safety for impurities and drug candidates across LEO Pharma production facilities and organization. You will serve as the primary point of contact for CMC, facilitating cross-functional collaboration between nonclinical safety and CMC and will work across multiple projects in our pipeline.

The Principal Regulatory Toxicologist will be responsible for writing and reviewing nonclinical documentation for c drug applications as well as assessing safety and risks related to drug/device production and use. You will play a key role in pivotal commercial discussions contributing with your holistic understanding of toxicology and have direct impact.

Your expertise will be essential for ensuring the safety of our products and make a significant contribution to our mission.

Your key responsibilities:

• Conduct safety and risk assessments of drug product impurities and process-related impurities.
• Evaluate extractables and leachables from production equipment and primary packaging materials
• Evaluate biological safety of medical devices.
• Plan, design, and monitor GLP toxicology studies at CROs.
• Prepare toxicological safety assessments using literature, Lhasa in silico models, and biological tests.
• Qualify impurities.
• Calculate permitted daily exposure and occupational exposure limits.
• Conduct safety evaluations of excipients and provide input for safety data sheets (SDS).
• Justify nonclinical drug product and substance specification limits.
• Evaluate in-licensing opportunities including due diligence
• Prepare regulatory documents such as IB, CTA, NDA/MAA etc.

To succeed in this role, we imagine that you have the following qualifications:

• A master’s degree or Ph.D. in life sciences (e.g. DVM) or a related field combined with a solid understanding of toxicology (preferably registered as DABT (Diplomate of the American Board of Toxicology and/or ERT (European Registered Toxicologist)).
• At least 5 years of industry experience within toxicology and risk assessment.
• Thorough knowledge of relevant test guidelines and regulations (including ICH M7 and ICH Q3A-D).
• Knowledge of Good Laboratory Practice (GLP).
• Proficient in in-silico evaluations and experienced in experimental work, either directly or through CRO collaboration.
• Good communication skills in English and Danish.
• Experience in data search and literature databases.

Your new team

You will join the Department of Translational Sciences, where you will work with bioanalytical scientists, toxicologists, pharmacokineticists, pharmacologists, bioinformatics and nonclinical documentation specialist.
 

Your application

Ready to take the next step in your career? Apply now to join LEO Pharma. We look forward to receiving your application!

At LEO Pharma, we believe in the power of teamwork and the potential of every individual. Join us and be part of a company that is making a real difference in the world of pharmaceuticals. Apply today and seize this incredible opportunity to build new areas in a land full of possibilities.

You do not need to upload a cover letter, but feel free to add a few sentences in your resume or CV on why this position has your interest.

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.

At LEO Pharma, we believe in the power of individuals to drive change. Our flat organizational structure empowers you to make a visible impact and offers versatile roles for professional growth. We value diversity and welcome applications from all qualified candidates, recognizing that our different perspectives, backgrounds, and attitudes enable us to make the best decisions. Join our passionate team at LEO Pharma and be yourself as we work together to make a difference.

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

Join us on our journey Beyond the Skin. Apply today!