Senior Global Regulatory Affairs Lead

Uniting Holding; Forest Row; On-site; GBP 45,000 - 60,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking a Senior Regulatory Affairs Executive. The successful candidate will support regulatory processes, including compiling eCTD dossiers and liaising with regulatory authorities. Candidates should have a B.Sc. in a scientific field and 5-7 years of experience in regulatory affairs. Strong organisational skills, fluency in English, and a detail-oriented approach are essential. This role offers an opportunity to work within a dynamic team focused on high-quality pharmaceutical products.

Qualifications

• Minimum 5 – 7 years in a regulatory affairs/R&D department.
• Experience in generic pharmaceutical applications essential.
• Knowledge of EU GMP, FDA regulatory, and pharmacovigilance guidelines.

Responsibilities

• Prepare, review, and compile eCTD regulatory dossiers for applications.
• Liaise with and respond to queries from regulatory authorities.
• Review and submit renewal and variation applications for existing Export MAs.
• Manage timelines for authority/customer queries, ensuring timely preparation.
• Oversee/manage department measurements in line with KPIs.

Skills

Organisational skills

Strong attention to detail

Time management

Team lead experience

Fluency in English

Strong customer focus

Ability to build relationships

Education

B.Sc. in Pharmacy, Chemical Engineering, Chemistry, or equivalent

Tools

MS Office

Job description

A leading pharmaceutical company in the United Kingdom is seeking a Senior Regulatory Affairs Executive. The successful candidate will support regulatory processes, including compiling eCTD dossiers and liaising with regulatory authorities. Candidates should have a B.Sc. in a scientific field and 5-7 years of experience in regulatory affairs. Strong organisational skills, fluency in English, and a detail-oriented approach are essential. This role offers an opportunity to work within a dynamic team focused on high-quality pharmaceutical products.