Regulatory CMC Lead (#987.100.548)
Vacatures in Amsterdam Noord Oost (Noord Holland), Nederland
An excellent regulatory affairs job opportunity has arisen for a Regulatory CMC Lead to work with a leading global contract research organisation at the forefront of drug development. The company boast an excellent working environment, challenging training and development programmes and exciting projects to work on. Job role: * The CMC Product Lead is accountable for the delivery of all regulatory milestones for higher complexity products through the product lifecycle in which responsible including assessment of the probability of regulatory success together with risk mitigation measures. * Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for projects of increasing complexity. * Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal. * Manage execution of CMC documentation including IND/CTA, NDA/BLA/MAA, post- approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems. * Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval and continued market supply of client's biopharmaceutical products worldwide. * Conduct all activities with an unwavering focus on compliance. Skills and Requirements: * Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data. * Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills. * Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving. * Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders. * Demonstrated flexibility in responding to changing priorities or dealing with unexpected events. * Demonstrated effective leadership, communication, interpersonal and negotiating skills.To Apply:Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable. In case you have difficulty in applying or if you have any questions, please call Badria Kahie on [Phone number removed] or upload your CV on our website - [URL removed] A full job description is available on request. ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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