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- Company Description
- Experis Engineering/Scientific is specialized in recruiting highly qualified scientific profiles; young potentials as well as experienced professionals. For one of our customers, active in the pharmaceutical industry, we are currently looking for a Senior Global Regulatory Manager
- Function Description
- Position holder will have global responsibility (for Regulatory Affairs) of given activities for a Project/Product within Company.
The purpose of the job is to:
• Provide input to/manage regulatory activities in order to obtain Marketing Authorisations for commercial products as rapidly as possible, with the best possible label, and to maintain these authorisations.
• Determine from a strategic and scientific perspective the content of relevant sections (technical, pre-clinical/non-clinical and/or clinical) of project/product specific documents submitted to regulatory agencies worldwide and ensure that these documents meet high scientific standards and regulatory requirements.
• Provide support in compiling/write briefing documents for internal governing bodies and other relevant internal documents (eg Global Regulatory Plan, KMS, etc.).
• Provide input into certain/all development stages of the project/product within a given product portfolio.
• Ensure, from an RA perspective, the execution of the product development regulatory strategy in order to ensure a complete and rapid development of the asset.
• Support the Global Regulatory Leader in providing robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs are in compliance with regulations and/or regulatory advice received from the agencies.
• Senior Global Regulatory Managers may act as leads or N+1 within the project, being accountable for the overall delivery of project-related activities, in collaboration with the members of the team.
- • Ph.D. or M.D in science or life sciences
• ideally 6+ years significant experience in regulatory affairs, or appropriate relevant experience.
• Fluent in English, with excellent writing skills.
• Broad knowledge is required and covers scientific as well as regulatory expertise.
• Previous experience in the development of medicinal products and obtaining licenses in different geographical areas is preferred.
• Ability to coordinate and execute regulatory strategy for a given project/product.
• Strategic thinker – ability to provide input into regulatory strategy and evaluate potential impact on overall project/product strategy.
• Ability to identify and escalate issues to the GRL and to propose mitigation strategies, maximize opportunities, with proven ability to develop collaborative relationships and have high impact and influence
• Ability to collaborate with other departments and teams in the delivery of outputs in a timely manner
• Problem Solver - Ability to resolve problems through resourceful use of information and contacts, meetings.
• Enterprise thinking – needs to understand the constraints and drivers of other functions and the potential impact on RA, including how RA may facilitate in achieving the overall goal.
- A challenging and interesting function in a company among the major players of the pharmaceutical industry.
Competitive salary package.