Senior Regulatory Specialist
Job Description
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 in our Ecolab Ltd. (Northwich) or near our Offices in Caerphilly or Baglan - hybrid working model optional.
How you'll make an impact:
This position contains tasks related to pharmaceutical regulatory area.
- Support Cross-Functional European Projects to 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:
- Bachelor’s 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 practice required for 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)
- Proficiency in 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 our nearly three million customer sites. Building on a century of innovation, our 48,000 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 to eliminating unnecessary complexities and embracing a beginner's mindset, continuously seeking new perspectives and innovative solutions to stay ahead in a rapidly changing world.
Ecolab’s commitment to diversity, equity and inclusion (DE&I) reflects our longstanding value of working together to integrate diverse perspectives to challenge ourselves, reach our goals and do what’s right.
Apply today and join one of the most ethical companies with over a hundred years of history.
Join Ecolab and help us protect what’s vital.
#li-eu
Nuestro compromiso con una cultura de inclusión y pertenencia
Ecolab está comprometido con el trato justo e igualitario de todas las personas colaboradoras y postulantes, y con la promoción de los principios de igualdad de oportunidades en el empleo. Reclutaremos, contrataremos, promoveremos, transferiremos y brindaremos oportunidades de desarrollo con base en las calificaciones individuales y el desempeño laboral, en todos los aspectos relacionados con el empleo, la compensación, los beneficios, las condiciones laborales y las oportunidades de crecimiento. Ecolab no discriminará a ninguna persona colaboradora ni postulante por motivos de raza, religión, color, credo, nacionalidad, estado de ciudadanía, sexo, orientación sexual, identidad y expresión de género, información genética, estado civil, edad o discapacidad.