Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and
Work Your Magic with us! Ready to explore, break barriers, and discover more? We know you’ve got big plans – so do we! Our colleagues across the globe love innovating with science and technology to enrich
* Manage case processing activities and safety risk management for both investigational and marketed products, ensuring compliance with internal procedures and regulations Client Details * European bio-pharmaceutical company, with rich development pipeline in immunology, oncology and
Join the team as a Payments Sales Analyst to be part of our growing Payments business! As a Sales Analyst in the Payments Corporate Sales team, you will be responsible for providing support to the Payments
* Manage timely product approvals for target indications in Japan * Align with global strategies and Japanese healthcare requirements * Collaborate across departments for regulatory compliance * Develop and update Japanese clinical development plans * Handle submissions and
YOUR IMPACT Are you looking to apply your communication and problem solving skills while becoming a market expert in finance? Our Regulatory Transaction Reporting team is seeking a professional who is looking to collaborate with various Operations
Key Responsibilities: • Execute action related regulatory compliance by having preventive and avoidance action doing risk analysis and management in RA part. • Take action to inquiry and/or instruction from Health Authority as a representative from Business
Job Description Responsible for all activities of Japan regulatory operations as a lead of regulatory operation in collaboration with Global RA, Japan R&D, and other functional areas within Biogen. Manage and maintain regulatory operational activities in drug development, NDA
* Responsible for supporting the Project Management group to ensure smooth and effective study delivery through organising of important documents and files. Client Details * European headquartered, pharmaceutical company with a mission to help patients with
Are you experienced in CMC regulatory affairs or in generating high-quality documentation related to drug manufacturing and marketing approval/maintenance? Do you have a strong understanding of CMC requirements in Japan? We are seeking a CMC Expert to
Description Who We Are At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, were the house of iconic brands - including Dr.Ci:Labo®, NEUTROGENA®, AVEENO®,
Fraud warning: Its common for scammers to create positions that look legitimate on other sites. To ensure your submission is considered, only apply for positions at Sensor Tower through our company website or through posts directly associated
Do you have a strong background in non-clinical activities? We are looking for a Non-Clinical Expert to join our team at Novo Nordisk. If you are ready to contribute to the development, submission, and approval of new
Job Description The Senior Manager / Manager of Clinical Pharmacology in Clinical Pharmacology & Pharmacometrics (CPP) serves as the clinical pharmacology country lead on program, clinical pharmacology, and clinical study teams, providing strategic leadership and expertise
* Responsible for preparation and submission of expedited and periodic safety reports to Regulatory Authorities, Ethics Committees and Investigators, adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures