Global Regulatory Affairs Specialist

Uniting Holding; Forest Row; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A pharmaceutical company in the United Kingdom is seeking a Regulatory Affairs Executive to assist in developing new products and obtaining licenses. The role entails preparing regulatory dossiers, managing authority queries, and supporting pharmacovigilance activities. Candidates should have a B.Sc. in a scientific field and 2-5 years of relevant experience. This position offers hybrid working options, fostering collaboration within a dynamic regulatory team.

Qualifications

• Minimum 2-5 years in a regulatory affairs/R&D department with experience in generic pharmaceutical applications.
• Strong computer skills in MS Office.
• Knowledge of EU GMP, FDA regulatory, and pharmacovigilance guidelines.

Responsibilities

• Prepare, review, and compile eCTD regulatory dossiers for Export Marketing Authorisation applications.
• Liaise with and respond to queries raised by the regulatory authorities.
• Set and manage timelines for responding to authority/customer queries.
• Review dossiers/responses prepared by Chanelle Pharma prior to submission.
• Preparation, review, and submission of renewal applications for existing Export MAs.

Skills

Organisational skills

Communication skills

Team collaboration

Attention to detail

Fluency in English

Customer focus

Education

B.Sc. in a scientific field (Pharmacy, Chemical Engineering, or Chemistry)

Tools

MS Office

Job description

A pharmaceutical company in the United Kingdom is seeking a Regulatory Affairs Executive to assist in developing new products and obtaining licenses. The role entails preparing regulatory dossiers, managing authority queries, and supporting pharmacovigilance activities. Candidates should have a B.Sc. in a scientific field and 2-5 years of relevant experience. This position offers hybrid working options, fostering collaboration within a dynamic regulatory team.