Senior Regulatory Specialist
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Job Summary
In this role you will be supporting the Regulatory Affairs Healthcare Team with implementation execution and management of pharmaceutical regulatory activities in UK and further European regions ensuring compliance and growth of our medicinal product portfolio.
The position could be based inour Ecolab Ltd. (Northwich) or near our Offices in Caerphilly or Baglan - hybrid working model optional.
How youll make an impact:
This positioncontainstasks related to pharmaceutical regulatory area.
- Support Cross-Functional European Projectsto drive innovation and efficacy
- Manage diverse maintenance activities of Medicinal Product Licenses (e.g. UK IE) and export market like:
- Preparation and submission of variations
- Creation and revision of packaging & promotional materials
- Update of internal and official databases
- Support audits & inspections
- Support the Pharmacovigilance system
- Monitor regulatory/pharmaceutical regulations for the relevant therapeutic areas and share information internally
- Assist other functions like customer service and tender business with regulatory expertise
Education:
- Bachelors degree or equivalent preferably in life sciences (pharmacy biology or similar).
Qualifications:
- Experience (minimum 2 years) of being in a similar position in the pharmaceutical industry or at health authorities
- Good knowledge of applicable pharmaceutical regulations preferably with UK & EU registration procedures
- Basic knowledge of related ethical code of practicerequiredfor GXP compliance
- Strong written and verbal communication and organizational skills
- Ability to work independently and collaborate effectively with cross-functional colleagues at all levels of the organization.
- Ability to multi-task and prioritize work.
- Fluency in English (speaking reading and writing)
- Proficiencyin Microsoft applications (Excel Word PowerPoint)
About Ecolab:
At Ecolab we prioritize our talent-first philosophy by creating the most capable and diverse team to excel at ournearly threemillion customer sites. Building on a century of innovation our 48000 associates help deliver comprehensive science-based solutions data-driven insights and world-class service to advance food safety maintain clean and safe environments and optimize water and energy use and improve operational efficiencies and sustainability for customers in the food healthcare life sciences hospitality and industrial markets in more than 170 countries around the world. Our solutions not only enhance operational efficiency but also contribute to sustainability and public health making a positive impact on the world. We are committed toeliminatingunnecessary complexities and embracing a beginners mindset continuously seeking new perspectives and innovative solutions to stay ahead in a rapidly changing world.
Ecolabs commitment to diversityequityand inclusion (DE&I) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves reach our goals and dowhatsright.
Apply today and join one of the most ethical companies with over a hundred years of history.
Join Ecolab and help us protectwhatsvital.
#li-eu
Required Experience:
Senior IC
About Company
Ecolab is the global leader in water, hygiene and energy technologies and services. Every day, we help make the world cleaner, safer and healthier – protecting people and vital resources.
