Senior Regulatory Affairs Lead – Submissions & CMC

Select Pharma Limited; United Kingdom; On-site; GBP 45,000 - 65,000; Full time

Job summary

A leading pharmaceutical company in the United Kingdom is seeking a Mid-Senior level Regulatory Affairs Specialist to provide regulatory input and support for new Marketing Authorisation Applications. The ideal candidate will have a strong background in regulatory submissions and CMC, with an emphasis on timely communication and compliance with UK and EU legislation. This is a full-time role offering the chance to work in a dynamic environment with multiple tasks and deadlines.

Qualifications

• Substantial regulatory experience across the full product lifecycle.
• Strong CMC regulatory experience, including preparation and review of Module 3 CTD.
• In depth knowledge of UK and European regulatory affairs legislation and guidance.

Responsibilities

• Responsible for full regulatory input and support for assigned products.
• Ensure regulatory submissions are made on time and delays communicated.
• Provide regulatory input on pharmaceutical development and CMC.

Skills

Strong due diligence and report writing

Planning and organisation skills

Excellent written communication skills

Strong negotiation skills

Education

Degree in a suitable scientific discipline

Job description

A leading pharmaceutical company in the United Kingdom is seeking a Mid-Senior level Regulatory Affairs Specialist to provide regulatory input and support for new Marketing Authorisation Applications. The ideal candidate will have a strong background in regulatory submissions and CMC, with an emphasis on timely communication and compliance with UK and EU legislation. This is a full-time role offering the chance to work in a dynamic environment with multiple tasks and deadlines.