At a Glance
- Tasks: Drive innovation in cross-functional projects and manage medicinal product licenses.
- Company: Join a leading pharmaceutical company focused on regulatory excellence.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Collaborative environment with opportunities to work across various functions.
- Why this job: Make a real impact in the pharmaceutical industry while ensuring compliance and safety.
- Qualifications: Bachelor’s degree in life sciences and 2+ years of relevant experience required.
The predicted salary is between 40000 - 50000 £ per year.
Responsibilities
- 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
Requirements
- Bachelor’s degree or equivalent, preferably in life sciences (pharmacy, biology, or similar)
- 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)
We think you need these skills to ace Senior Regulatory Specialist in Northwich
Regulatory Knowledge
Pharmaceutical Regulations
UK & EU Registration Procedures
GXP Compliance
Communication Skills
Organisational Skills
Cross-Functional Collaboration