Are you someone with good regulatory submissions experience looking for developing your career within this area?
We are recruiting for a Regulatory Submissions Sr. Coordinator (Senior Start-Up Specialist) to work sponsor dedicated into a top 5 pharmaceutical company to be based in Belgium.
As part of our client team you will be dedicated to the Functional Service Provider FSP project you will bring your specialised discipline to a core team working directly with one sponsor. Whether your specialisation is in clinical monitoring, clinical project management, data management, biometrics or pharmacovigilance.
Each FSP offers a unique opportunity to be a part of the drug development cycle and see a product through to launch. There are multiple partnerships giving you the variety and the flexibility to stay with sponsors, try a new external secondment or work in house
Role main responsibilities
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Prepare, review, and file initial clinical trial applications to regulatory local authorities and Ethics committees and international regulatory agencies;
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Ensure submissions comply with applicable regulations and guidance documents;
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Advise sponsors on changing regulations and compliance requirements;
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Prepare and submit responses to queries and amendments to clinical trial applications;
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Track submissions and ensure timely filing of documents;
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Collection of essential documents and preparation essential documents packages for drug release.
With the support of exceptional people and an energised purpose, you'll be empowered to own your career journey with dedicated mentoring, training and personalised development planning.
Education/Qualifications:
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University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical or laboratory technology
Experience:
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Good organisational and time management skills
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Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC and other applicable regulations/guidelines; familiarity with investigator start up documents; previous interaction with operational project team and investigative sites preferred.
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Language skills: English, Dutch and French (3 languages is a must)
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Excellent communication skills, oral and written.
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Self-motivation with the ability to work under pressure to meet deadlines
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Works well independently as well as in team environment.
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Detail and process oriented
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Positive attitude and approach
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Interact with internal and external customers with high degree of professionalism and discretion
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Multi-tasking capability.
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Good computer skills with good working knowledge of a range of computer packages
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Ability to lead and develop junior staff
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Flexible and adaptable to a developing work environment
