Director of Regulatory Toxicology Are you ready to drive innovation in wellness and healthcare? We're seeking a visionary Director of Regulatory Toxicology to lead the scientific integrity of our portfolio, developing safe, effective, and high-quality products that set new standards in health and wellness. About UsWe are addressing unmet medical and consumer needs. Our current focus includes groundbreaking work with cutting-edge science to create transformative solutions. Your RoleConduct toxicological risk assessments for innovative drugs and consumer products.Oversee preclinical programs, ensuring regulatory compliance and quality.Collaborate with cross-functional teams and manage third-party providers.Implement new methodologies to advance functional development.What We're Looking ForDegree in life sciences with toxicology expertise (e.g., Certified European Registered Toxicologist).Proven experience in toxicological assessments and preclinical studies.Strategic thinker with a deep understanding of regulatory environments.Leadership experience in cross-functional or matrix organisations.Why Join Us?This is a rare opportunity to shape the future of health and wellness while working with a passionate team committed to innovation. Apply NowIf you're ready to make a real impact, we'd love to hear from you!

CSV Specialist (m/f/x) | Köln/Bonn area | PharmaceuticalsAs a CSV Specialist (m/f/x) for this global pharmaceutical company, you will be responsible for the validation of computer systems within the engineering department. You will be part of a collaborative, exciting work environment and implement your expertise. These tasks are waiting for you:Ensuring the validated state of all GxP-relevant computerized systems in different areas in accordance with GMP regulationsValidation of computerized systems for new acquisitions and existing installationsProject management for computer system-related topics in projectsRecording and management of validation-relevant computerized systemsCreation and review of validation documentation and SOPs in the field of CSVConducting risk analysis and change managementTechnical collaboration in the development, optimization, and implementation of processes and projectsCooperation with interdisciplinary teams to ensure system integrity This completes your profile:Completed degree in Computer Science, Business Informatics, or a comparable technical fieldSeveral years of practical experience in Computer System Validation (CSV), ideally in the chemical industry or other regulated sectorsExperience in the validation and implementation of complex IT systems and software solutionsKnowledge of regulatory requirements (e.g., GMP) and strong familiarity with the GAMP5 guidelinesExcellent knowledge of IT architecture and relevant technologiesFluent German and good English skills, both written and spokenIndependent, analytical, and structured working style with strong problem-solving skills This is what the position offers:Interesting tasks with great potential for growthFlexible working hours in a 37,5h work week with 30 days holidayHybrid working modelOther benefits such as bike leasing, group accident insurance, affordable meals in the cafeteria, free employee parking Information about our client:Our client is a global pharmaceutical company dedicated to providing access to high-quality, affordable medicines. The company focuses on improving global healthcare by ensuring the availability of essential treatments for cardiovascular diseases, infectious diseases, oncology, and more.

Specialist (m/f/x) Qualification & Software Validation | Pharmaceuticals | Darmstadt / Mannheim AreaAs a Specialist (m/f/x) for qualification and software validation for this exciting chemical and pharmaceutical company, you will be responsible for the hands-on qualification of production facilities. You'll have the opportunity to contribute your own ideas and experiences. These tasks are waiting for you:Preparing periodic reviews, annual requalification, audit trail reviews for existing pharmaceutical production equipment, such as filling systems for liquids, pure media systemsConduct software validationCompiling URS and conducting risk evaluations in alignment with current GMP requirementsDrafting and revising SOPs related to equipment handling and sanitation proceduresGenerating reports for deviations, managing change control processes, and overseeing CAPA measuresProviding support during external auditsPlaying an active role in enhancing GMP adherenceThis completes your profile:Successfully completed studies in natural sciences, pharmaceutical technology, chemical engineering or similar fieldsExperience in pharmaceutical production and strong knowledge of GMP compliance as well as qualification of systemsExperience in preparing recurring periodic assessments for existing systems and conducting audit trail reviewsTeam-oriented and structured work approach, as well as analytical thinkingVery good German and English language skills both written and spokenWhat the company offers you:Flat hierarchies with room for your own ideasFull-time position with 37.5 hours/week - Friday is a half working dayHybrid working environment possibleCompany pension planMeal allowanceOn-site parkingCorporate benefits About our client:Our client is a specialized company in the development and manufacturing of chemical products and pharmaceuticals. The company is known for its quality, innovation, and customer satisfaction, serving customers in various industries worldwide.

SciPro are continuing to partner with an exciting, fast-growing global organisation who are on a mission to revolutionize healthcare, addressing unmet patient and consumer needs. We are supporting their search for an experienced individual to lead global regulatory strategies for their assigned product. As Director - Global Regulatory Lead, you will be responsible for shaping and executing regulatory strategies and play a key role in ensuring regulatory approvals, optimizing product labeling, and engaging with global regulatory authorities.Key Responsibilities:Develop and implement global regulatory strategies to support product approvals and labeling optimization.Lead the preparation of regulatory submissions, including briefing documents, IND dossiers, and CTAs.Manage communications and meetings with global regulatory agencies.Provide strategic regulatory guidance to cross-functional teams, ensuring compliance with global regulations.Key Requirements:Advanced scientific degree with significant experience in regulatory affairs.Strong communication skills, with the ability to simplify complex regulatory topics.Proven success in negotiating with global health authorities.If you're looking for a role where you can make an impact in a fast-evolving healthcare landscape, we'd love to hear from you.