Pharmacist by training, post-graduated in Regulatory Affairs. 17+ years of experience include work in all stages of pharmaceutical development, in various therapeutic indications and in various leadership Regulatory Affairs positions

Pharmacist by training, certified in regulatory affairs since 2016 - RAC EU. 16+ years of experience in (bio)pharma and medical devices industries. Expert in EU procedures, for product in any stage, from early development through marketing authorization to life-cycle maintenance procedures. Liaison with the authorities and submission expert, with proven track record of high-quality submissions and successful resolution of complex requests for further information. Project lead, with history of successful setting, execution, coordination, and governance of multiple diverse scope regulatory projects, with high-standard quality assurance oversight. Committed to bringing excellence, simplicity and high-standard compliance in execution and governance of outsourced regulatory projects.

Diploma in Chemistry with a specialization in Enzyme Technology during PhD and Post-Graduate studies. Over 15 years of industry experience in Pharma and Biotech, focusing on Regulatory Affairs, along with 3 years in Pharmacovigilance. Skilled in Regulatory Affairs leadership roles, including team building and process implementation from inception. Responsible for various global RA projects in all stages of development and indications including US, EU, Emerging Markets (e.g. Brazil, India, China). Core expertise includes Due Diligence, Authority meetings (EU Scientific Advice, FDA Type meetings), Coordination of complex submissions (e.g. INDs, PIPs/PSPs), Regulatory Intelligence & Impact Assessments, Regulatory Strategy input to cross-functional teams, and also hands-on submission work in the clinical trial and post-marketing setting. In Pharmacovigilance, overseeing of process development for Clinical Safety in a Biotech, validated via a regulatory inspection. Extensive experience in vendor management. Regular speaker at conferences, member of several industry associations and initiatives

Pharmacist by training, certified in regulatory affairs and project management. 16+ years in clinical development, PM and clinical operations in pharmaceutical, biopharma and CRO companies, including start-ups. Managed all aspects of complex international clinical research projects in various indications.

PhD in Medicinal Chemistry and graduated in International Regulatory Affairs 16+ years of regulatory affairs experience. Provides a broad range of consulting support for various projects including: quality expert (draft of IMPD, EDMF / ASMF, CEP, CTD, ASEAN CTD), EU MA management (all submission types), regulatory strategy and due diligence, scientific advice, clinical trial application, RA training. Founder and owner of LMDB Consulting 34

Regulatory affairs expert with over 18 years’ experience within the pharmaceutical, biotechnological and consumer healthcare sectors. Strategic regulatory affairs input into product development plans. Extensive exposure to marketing authorisation (MA), clinical trial authorisation (CTA) applications, labelling. CMC and review of promotional materials for product launches. Completed several product lifecycle management projects across multiple therapeutic areas including antivirals/renal/neonatology, oncology, immunology, central nervous system (CNS), dermatology, thrombosis using national, mutual recognition, decentralised and centralised procedures.