Senior Manager, Regulatory Sciences

vor 2 Wochen

germany ProPharma Group Vollzeit

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. Responsibilities: Independently leaddiscreet client projects (as assigned),and lead project teams through all project phases to ensure efficient project executionand contribute to larger projects. As required, author global nonclinical/clinical aspects of regulatory documentation including environmental risk assessments, development plans, briefing books, orphan designations, paediatric investigation plans, marketing authorisation applications, contributing to gap analyses and regulatory strategies.  Project Management of assigned projects in accordance with internal procedures – including approval of time entry and invoicing, budget monitoring, client liaison and service growth. Provide expert guidance and technical expertise, manage complex tasks and contribute to overall project strategy. Lead interactions with clients and regulatory agencies on defined projects. Build strong client relationships, manage client expectations and participate in client strategy discussions. Support development of client budgets and business proposals. Stay informed of relevant regulatory developments and contribute to regulatory/industry workshops, trainings and calls for collaboration . Contribute to the ongoing improvement of internal regulatory processes and procedures. Mentor and coach junior staff, line management if necessary. Requirements: Advanced degree (MSc/PhD) in a relevant field preferred. Bachelor's degree in a life science field (e.g., biology, pharmacy, pharmacology, toxicology) or a related discipline necessary. 8-10+ years’ experience within regulatory sciences for development products preferred Expertise with nonclinical/clinical regulatory writing and advanced knowledge of nonclinical/clinical strategies for development products. Experience of leading and delivering successful projects within budget and timeframe. Experience managing client relationships within a consultancy setting preferred. Demonstrated leadership and client-facing skills. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. ***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

  • Regulatory Lead, Marketed products

    vor 3 Wochen

    Germany Discover International Vollzeit

    The Global Regulatory Affairs Lead (Oncology – Marketed Products) is responsible for developing and executing global regulatory strategies to support the lifecycle management of marketed oncology products. This role provides strategic and operational regulatory leadership across multiple regions, ensuring continued compliance, label optimization, and...

  • Senior Medical Science Liaison

    vor 3 Wochen

    Germany wax. Vollzeit

    Our client has a fantastic opportunity for a Senior Medical Science Liaison (MSL)/ Regional Medical Advisor to join the Medical team. This role will focus on the Central/Southern part of Germany. This role will support their portfolio of products and relay field-based clinical/medical insights in order to support the future strategy.This position will...

  • Account Manager, Life Sciences Products

    vor 2 Wochen

    Remote - Germany BLS Azenta Life Sciences Vollzeit 50.000 € - 80.000 € pro Jahr

    Azenta Germany GmbHAt Azenta, new ideas, new technologies and new ways of thinking are driving our future. Our customer focused culture encourages employees to embrace innovation and challenge the status quo with novel thinking and collaborative work relationships.All we accomplish is grounded in our core values of Customer Focus, Achievement,...

  • Drug Regulatory Affairs Manager

    Vor 4 Tagen

    Marburg, Germany Aenova IP Vollzeit 40.000 € - 60.000 € pro Jahr

    Drug Regulatory Affairs Manager (m/w/d) Schwerpunkt Regulatory Operations (Teilzeit)für den Standort Marburg, DeutschlandSie möchten einen wertvollen Beitrag für die Gesundheit von Patient*innen leisten? Und eigenverantwortlich etwas wirklich Sinnvolles bewirken? Dann freuen wir uns auf Sie Excellence beyond manufacturing – dafür stehen wir als Aenova,...

  • Junior Project Manager

    Vor 4 Tagen

    Kassel, Germany, Discovery Life Sciences Vollzeit 40.000 € - 80.000 € pro Jahr

    About Discovery Life Sciences:Discovery Life Sciences is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We support new therapeutic approaches with reliable biomarker data in clinical...

  • Senior Project Manager

    Vor 6 Tagen

    Friedrich-Ebert-Straße , Bergisch Gladbach, Germany Miltenyi Biomedicine Vollzeit 60.000 € - 120.000 € pro Jahr

    Company Description Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are...

  • Sample Manager

    vor 1 Woche

    Kassel, Germany, Discovery Life Sciences Vollzeit 40.000 € - 60.000 € pro Jahr

    About Discovery Life Sciences:Discovery Life Sciences is a leading provider of highly characterized human biospecimens and cellular starting materials to advance cell and gene therapy and precision medicine programs for cancer, infectious disease, and other complex conditions. We support new therapeutic approaches with reliable biomarker data in clinical...

  • Medical Science Liaison

    vor 3 Wochen

    Germany Advanced Clinical Vollzeit

    Clinical Trial Educator – EuropeLocation: Remote, EuropeIndustry: Biopharmaceutical / Clinical DevelopmentTherapy Area - Rare disease About the RoleWe are seeking an experienced Clinical Trial Educator (CTE) to support clinical development programs across Europe. This position offers the opportunity to work directly with leading investigators and study...

  • Senior Clinical Research Associate

    vor 3 Wochen

    Germany AL Solutions Vollzeit

    Senior Clinical Research Associate – Germany (Home-Based, French Speaking)Chloe O’Shea is pleased to be working with a small global CRO recognised for driving innovation and excellence in clinical development. We are seeking an experienced Clinical Research Associate to join a sponsor-dedicated team, home-based in Germany. This is a unique opportunity to...

  • Senior Team Lead

    vor 3 Wochen

    Germany Odin Global Vollzeit

    Senior Team Lead – Project DevelopmentEuropean IPPCompany OverviewFounded in the early 2000s, this European IPP is an integrated renewable energy developer and independent power producer operating across multiple international markets. The business manages the full project lifecycle of utility-scale solar and energy storage assets — from initial...