Overview
Regulatory Operations Specialist (Entry level), As a key specialist of our Global Regulatory Operations, Medicines Post Launch Team, you will support with the strategy and execution of key compliance projects and post-launch activities for our existing portfolio of Medicinal products. You may also be asked to support work within a different classification area from time to time. In your role you will ensure operational excellence of your area of responsibility and will deliver activities in a timely manner to a high standard in line with our operating model and internal best practice. Supporting a complex and diverse set of regulatory requirements and landscape overview across multiple markets to enable dossier maintenance and compliance post launch.
Responsibilities
* Responsible for delivery of high quality submissions to agreed operations time frames and collaborating across partner functions to ensure timely delivery of all information required.
* Supporting non dossier maintenance activities e.g. GMP documentation support for any/all of the Reckitt medicinal manufacturing sites globally
* Ensuring all activities are performed in line with the operating model and internal best practice including the compliant use of all systems to ensure audit readiness at all times
Qualifications
* Degree in a relevant scientific discipline - such as Chemistry, Biological Sciences, Microbiology, Pharmacy.
* Some knowledge of the Regional and Global regulatory environment
* An ability to support work on multiple projects at any given time and a capability to prioritise and manage your own workload independently, seeking support from the regulatory project lead as needed.
* Strong communicator able to liaise with stakeholders of all levels
* Agile and can demonstrate this by being able to work across different classifications as needed (with supervision and guidance where required).
* A creative, results focused individual with a passion for working collaboratively and with empathy with cross functional teams, built on technical credibility, trust and strong relationships.
* The ability to consistently deliver work to time, cost and quality standards in a high-pressure environment.
* You strive for a high level of accuracy in authoring and or reviewing documentation for regulatory purposes, with a focus on ensuring the level of registered information is appropriate.
* Able to review and summarise regulatory /technical information both orally and in written communications.
About Us
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
Research & Development
In Research and Development, we\'re full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality.
We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
The size of our organisation means you\'ll have the opportunity to learn and work in different functions within R&D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
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