Regulatory Submissions Specialist
Salary is DOE
Our client, a global pharmaceutical company based in Sandwich, is currently looking to recruit a Regulatory Submissions Specialist to join their growing team on a 15 month contact starting in March 2021.
This role is responsible for the implementation of global CMC regulatory strategies specific to our products. Working in partnership with key stakeholders including Project Management, QA & Manufacturing
* Support to the authors both internal to our client and external (3rd party Vendors) on pre-publishing and submission readiness activities
* Support to the Global Regulatory Leads in delivering various types of submissions
* Provide cross team, and external partners with regulatory expertise in line with CMC requirements
* Expand on and build strong relationships with both internal and external partners to achieve global regulatory goals
* Apply detailed knowledge and understanding of the major markets' submission requirements
* Lead and participate in the prep work of CMC components and regulatory submission. would include clinical trial & variations as well as filing submissions for leading markets in line with regulatory needs.
* Support the dossier authors on the regional submission ready requirements
* Liaise with global and regional functional lines, and 3rd party Vendors in order to ensure that our clients' document standard is represented
* Bachelors degree (or equivalent) in scientific field is essential
* Proficient in Adobe Acrobat (with plug-ins), MS Excel and MS Word
* Detailed knowledge of document management systems such as Documentum
* Demonstrated project management, interpersonal and leadership skills
* Knowledge of US and European pharmaceutical regulations and guidelines as they pertain to regulatory submissions/publishing requirements
* Understanding and practical experience of submission readiness/publishing tools for MAA's, CTAs NDA's, ANDA's, BLA's and IND's in eCTD format
If you would like to discuss this position in further detail please call Nicole on freephone 0808 168 1474 or email
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