Leads a team or complex scope of work to ensure high quality delivery of innovative protocols and data packages for CSRs and Regulatory Filings. Oversees all clinical studies...
Responsible for all operational aspects of clinical trial oversight including the delivery of every study on time within budget and scope in compliance with GCP’s, SOPs and...
Internal manufacturing processes in scope (Milling, PCB assembly and Assembly line); Close connection to manufacturing areas; Technical knowledge of manufacturing processes to...
Execute QP responsibilities, duties, batch certification and disposition for products in the EU as defined in EU Council Directives and Eudralex Volume 4, Annex 16; Manage QPs and...
The Associate Director, Regulatory Affairs Marketing Authorisation is primarily responsible for providing strategic and operational direction, oversight and hands-on, day-to-day...
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LINK Medical is searching for a Senior Clinical Project Manager (CPM) in all our other Swedish offices, Oslo, Copenhagen and Berlin to manage a global study. As a CPM you will be...
Lead the individual case safety report (ICSR) management and processing team at Daichi Sankyo Europe (DSE) which focuses on ICSR case handling. Performing Data Management of...
Do you have a flair for organizing and directing the documentation for regulatory submissions? Are you motivated by contributing to making a difference by working in a vaccines...
The position requires strong management and leadership skills, knowledge of sterile drug product manufacturing, and a deep understanding of formulation development of therapeutic...
Lead and manage the entire registration process in ensuring approvals of new products, manufacturing permits, import permits, and amendments to products. Lead regulatory strategy...
Representing GRA in the Global Project Core Team and chair the Global Regulatory Project Team for key development projects within the RMMH portfolio, providing regulatory strategic...
Manage all regulatory work related to Reckitt’s Health Business Unit’s products (e.g.: OTC, biocides). Ensure compliance with all local regulations and with company Regulatory,...
The Country Medical Affairs Director DACH will lead, continuously develop, and be accountable for the country Medical Affairs function and team, ensuring Medical Affairs represents...
Perform the disposition of drug, combination, and device products. Ensure batch disposition process is compliance with company practices and regulatory requirements. Support and...
Act as Subject Matter Expert for respective Sobi products. Experienced in formulation process development for aseptic formulation. Ensure reliability and effectiveness of Drug...
The incumbent is a Medical Director within a pipeline program and will be responsible for supporting clinical trials and the development strategy. The successful candidate should...
As a key partner to the business, the Supplier Relationship Manager of External Manufacturing and Sourcing (EM&S) is responsible for contributing to and executing the company’s...
Reporting directly to the Quality Assurance (QA) Director of Grifols Worldwide Operations (GWWO), The QA Packaging Manager will be responsible for a range of GMP and product...
Act as responsible person on Karo Healthcare WDA; Assuring relationship building with Karo partners in co-operation with commercial, Operations, Regulatory and PV teams...
The Clinical Trial Manager is responsible for the day-to-day leadership and management of monitoring services for clinical projects, including direct communication and interaction...
You strengthen roles and responsibilities for individual team members incl. performance reviews and development plans; You define and prioritize individual deliverables across the...
Lead the coordination and oversight of medical function within the framework of Sanofi Vaccines business strategy and area of expertise across PME (Partnership Markets Europe)...
Serves as interface between Company, sponsors, vendors, and other departments in the area of Safety and Pharmacovigilance; Line management responsibilities for Safety and...
Provide best in class regulatory support & input throughout the whole Innovation process with product ideas ranging from food supplements (based on vitamins, minerals,...
Managing the mRNA production unit. Giving leadership to teams of production leaders, managers, supervisors and operators. Build up and sustain a successful, high performing team....
The Neuroscience Medical Director is responsible for leading the UK & Ireland Neuroscience medical affairs team. This includes leadership of the people, strategy and programs that...
Assessment of drug candidates, impurities, metabolites or chemicals for their mutagenic and/or genotoxic potential in the toxicology department of the Innovation Campus Berlin...
Providing leadership for all Quality activities related to the mammalian organization; Sets the strategy of the quality function for mammalian manufacturing, developing and...
Responsible for leading the development and delivery of innovative global regulatory strategies for an assigned global product. Oversight of global regulatory activities (where...
Develop global regulatory CMC strategies to ensure acceptance, rapid review and approval of marketing applications, supplements/variations, clinical trial applications and other...
The Director/Senior Director, Medical Affairs is responsible for providing strategic and operational leadership to the Medical Affairs function for the respective country or region...
The Head Medical Affairs follows the medical aspects of the lifecycle process of a product: from clinical trials to post-marketing studies. He/she ensures medical contact persons...
The Clinical Program Leader (CPL) leads and manages the cross-functional clinical program team, and ensures delivery of clinical activities to agreed timelines, budget and quality...
Plan and execute quality systems requirements related to Edwards warehouse and distribution and related processes. Identify and lead process improvement activities. Provide project...
Sr, Director, Statistical Programming provides leadership in building, engaging, and growing the EU Statistical Programming team working closely with Stats Programming Leadership...
Be responsible for GDP compliance and provide oversight of GDP vendors activities; Handle GDP quality related issues both internally and externally with e.g. Sobis GDP vendors,...
Define and implement the company's quality policy, under the responsibility of the Responsible Pharmacist (RP), in all of the “exploitant”'s pharmaceutical activities (Quality...
This contract role has been created to provide end-to-end management, with HEOR (Health, Economics and Outcome Research), of the HTA (Health Technology Assessment) submissions for...
Provide strategic medical and scientific expertise in support of all affiliate Medical Affairs deliverables and cross-functional activities in a collaborative working environment;...
The role supports the organisation in identifying key payer customer stakeholders, co-creating, and executing local engagement plans in alignment with HEOR, P&GA and Key Account...
The Director, Regulatory CMC will be responsible for building an international arm of the Seagen Regulatory CMC group and immediately managing and developing staff in the EU and...
Proactively manage medical-scientific stakeholders and create value for patients through medical and scientific stakeholder engagement, medical-scientific projects and scientific...
Responsible for the development of the entire Brand Plan and of Functional Plan, coordinating the input of all relevant BT members; Responsible for building Digital Transformation...
This position will be responsible for managing Contract Manufacturing Organizations(CMO) for Biologics such as antibody and so on from technical and production planning...