Lukasz Czekala, Ph.D., DABT, ERT

SRA Toxicology Manager

Switzerland

About

I am a Diplomate of the American Board of Toxicology (DABT), European Registered Toxicologist (ERT), and PhD scientist in Translational Biomedicine with a strong foundation in biotechnology and over a decade of experience at the intersection of toxicology, regulatory science, and product compliance. My career spans FMCG, consumer health, cosmetics, medical devices, and tobacco industries, where I have developed deep expertise in pre-clinical toxicology, human health risk assessment, and regulatory toxicology. I specialize in global regulatory submissions (PMTA, EU TPD, EU MPs, MDR, PIF), ensuring products meet rigorous scientific and legal standards for safe and compliant market entry worldwide. I am passionate about applying New Approach Methodologies (NAMs) and Next Generation Risk Assessment (NGRA) frameworks to advance product safety and sustainability. My work bridges scientific rigor and regulatory strategy, enabling evidence-based decisions and successful product stewardship. I thrive in cross-functional environments, collaborating with R&D, quality, regulatory, and compliance teams to deliver impactful solutions. With this unique combination of scientific depth, regulatory insight, and leadership experience, I am well positioned for roles in regulatory agencies, scientific affairs, or product safety leadership—helping shape future regulatory frameworks and safeguard public health. Key highlights:  PhD in Translational Biomedicine  Diplomate of the American Board of Toxicology (DABT)  European Registered Toxicologist (ERT)  MSc & Engineer in Biotechnology  Leadership in Product Safety & Pre-clinical Assessment  Expertise in Quantitative Risk Assessment (QRA)  Global Regulatory Submissions: PMTA, EU TPD, EU MPs, MDR, PIF  Regulatory Toxicology & Human Health Risk Assessment  Inhalation Toxicology & Next Generation Products  Application of NAMs, NGRA, and TT21C  Experience across Medical Devices, Cosmetics, Personal Care, Tobacco  Strong background in R&D, Project Management, and Stakeholder Engagement

Experience

  • SRA Toxicology Manager at JTI
    Oct 2024 - Present · 1 yr 10 mos

  • Senior Manager - Head of International Toxicology & Product Safety at Church & Dwight Co., Inc.
    Sep 2022 - Sep 2024 · 2 yrs 1 mo

    Leadership in ingredient and product safety management including risk assessments and managing safety testing programs to ensure product safety across a diverse product portfolio worldwide Responsible for the safety of all raw materials and finished products assessments for cosmetic, over the counter, medical device, and personal care products Lead on the identification, assessment, and evaluation of the scientific and regulatory requirements to allow for entry of products into markets Design and coordinate safety and clinical tests for new ingredients and products at outside contract laboratories and academic sites Preparation and management of CPSRs

  • Imperial Brands PLC (Bristol, England, United Kingdom)
    • Regulatory Scientific Strategy Manager
      Oct 2021 - Aug 2022 · 11 mos

      Defining the strategy for the scientific and regulatory framework requirements for all product categories, in all markets, ensuring a consistent approach, to secure favourable regulatory outcomes. Driving and leading the operational and scientific strategy for all Next Generation Products related activities for US and pre-authorisation markets, ensuring necessary regulatory science is conducted to enable on time and successful product launches in line with commercial plans.

    • Senior Pre-Clinical Toxicologist
      Jan 2021 - Sep 2021 · 9 mos

      Group Science & Regulatory Affairs Science Lead on a product category (ENDS), managing scientific and regulatory workstreams from ideation to launch. Propose, implement and manage new testing strategies to support Product Stewardship and Scientific Research and Harm Reduction for the Next Generation Products. Leading the toxicology workstream of the Premarket Tobacco Product Application (PMTA) for the submission to the US FDA on Electronic Nicotine Delivery Systems (ENDS). Strategic Stakeholders and International CRO Management.

    • Pre-Clinical Toxicologist
      Nov 2018 - Dec 2020 · 2 yrs 2 mos

      As the Pre-Clinical Toxicologist, I am designing and leading the research programme projects in the field of non-clinical toxicology and the Toxicity Testing in the 21st Century methods implementation for the assessment of novel, alternative next generation products. A Lead Toxicologist for the submission to US Food and Drug Administration (Premarket Tobacco Applications) for Electronic Nicotine Delivery Systems. Group Science & Regulatory Affairs Science Lead for the EVP product category, responsible for planning and delivery of the Safety Assessment Framework withing the Ideation to Launch.

  • Project Engineer/In vitro Toxicological Laboratory Scientist at World Natural Care
    Feb 2014 - Jul 2016 · 2 yrs 6 mos

    - Biological/toxicological laboratory management - Risk assessment and regulatory toxicology for the product compliance under the EU Cosmetic Regulation - R&D an involvement in current company projects - In vitro toxicological tests on 3D organotypic models (skin, eye, mucosal) - In vitro Phototoxicity (3T3 NRU PT, NHu-3D) evaluation - Mammalian cell cultures - proliferation, cryobanking, cytotoxicity - Implementation of the GLP principles - Contract research organizations management - LIMS

  • Research Associate - Department of Plant Physiology at Poznan University of Life Sciences
    Aug 2012 - May 2014 · 1 yr 10 mos

    - Multi-elicitation process of plants in vitro cell/seedling cultures with liquid extraction of secondary metabolites for pharmaceutical application - Transfer of the know-how from a foreign partner university and cell culture lab establishment - Primer designing, PCR/RT-qPCR - Protein electrophoresis - Study of plants defense mechanisms via phenylpropanoid pathway enzymes activity - Synthetic nucleotides - Dinucleoside polyphosphates NpnN′s - High Performance Liquid Chromatography (HPLC)