Director Regulatory Data Management

The organisation

Your new employer is a rapidly growing innovator in the healthcare sector, committed to transforming the healthcare landscape through cutting-edge solutions. They provide Services and Solutions to Support the Life Sciences Industry with Regulatory Affairs Operations and Strategy. They are dedicated to improving patient outcomes through intelligent regulatory compliance. They support companies in ensuring their regulatory compliance across the globe by providing trained resources, knowledge, and technology to assist their clients in their day-to-day operations.

The position

As a Director Regulatory Data Management you will be responsible for delivering high quality services and projects to your companies’ customers for data management. You will report directly into the Chief Delivery Officer. You will lead a team specialized in the submission and reporting of data (primarily) describing Medicinal- and pharmaceutical products, Organizations and Substances. The focus of the role is on ensuring the highest possible data quality and compliance with existing guidance, regulations, and data standards. In this role you will closely cooperate with the Regulatory Affairs (RA) departments of your companies’ customers and you will contribute to the correct use and implementation of data to support their business processes.

Typical activities include providing consultancy and other support related to process development, data cleansing and remediation activities, vendor selection and system implementation. You coordinate daily operations, project and resource planning for the Data Management group and establishes and maintains an excellent working relationship with customers. You can also be involved in the development of the in-house developed and maintained solutions. You will function as a Subject Matter Expert, where the responsibilities are ensuring translating business needs to functional requirements and supporting Software Development activities. You will also support pre-sales and marketing initiatives related to regulatory data management function and finally, you will act as line manager for individual team members and act as a coach on achieving goals and developing necessary skills of all team members within the department.

Candidate profile

To be successful as a Director Regulatory Data Management, you have higher professional education in a Life Sciences field. You combine this background with expert knowledge of Regulatory Affairs, in particular regulatory information management, with at least 10+ years of adequate professional experience. You also have knowledge of and experience with the drug development process, regulatory filing guidelines and electronic submissions, as well as experience with data management tools and platforms relevant to the life sciences industry. If you also have experience with software development this will be considered a plus. You have affinity with Information Technology and automation and you are proficient with computer programs such as MS Office and Adobe Acrobat. You are quality focused and you have a transparent systematic and consistent approach. You are fluent in English, Dutch is not required for this position. You have a passion for data quality and a commitment to continuous improvement and you have good analytical skills. You are able to manage and deliver through others in a matrix environment and you are used to working in a demanding environment with a strong focus on quality and timelines. You are able to work on multiple projects at the same time and you are eager to learn an array of technical tools.

Because this is a Director role you also have strong leadership abilities, good organizational skills, including efficiency and collaboration in a team environment. You have good interpersonal skills, including communication, presentation, persuasion, and influence. Finally, you are flexible and able to adapt to emerging situations.
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The offer

Your new employer offers you a suitable salary and secondary benefits that match your experience and expertise.

Interested?

You can apply for this position by using the link below.