EMEA Regulatory Affairs Director – Rare Diseases

Jobgether; United Kingdom; Hybrid; GBP 150,000 - 200,000; Full time

Job summary

A leading healthcare company in the UK is seeking an Associate Director Regulatory Affairs to shape and execute regulatory strategies across the EMEA region. The role involves defining regulatory strategies, providing guidance to cross-functional teams, and managing regulatory documentation. The ideal candidate has over 8 years of experience in regulatory affairs, fluent English, and knowledge of GCC region regulations. This position offers competitive compensation and a flexible hybrid work model that balances on-site collaboration with autonomy.

Benefits

Competitive compensation

Generous vacation allowance

Comprehensive wellbeing benefits

Tuition sponsorship

Fitness reimbursement

Qualifications

• Minimum of 8 years of experience in regulatory affairs within pharmaceutical or biotech industry.
• Strong knowledge of global regulatory frameworks and drug development processes.
• Proven experience with EMEA regulations and GCC region.

Responsibilities

• Define EMEA regulatory strategies for products.
• Provide regulatory guidance to cross-functional teams.
• Review regulatory documentation including major submissions.

Skills

Regulatory affairs experience

Communication skills

Stakeholder management

Education

Bachelor's degree in life sciences or related field

Advanced degree

Job description

A leading healthcare company in the UK is seeking an Associate Director Regulatory Affairs to shape and execute regulatory strategies across the EMEA region. The role involves defining regulatory strategies, providing guidance to cross-functional teams, and managing regulatory documentation. The ideal candidate has over 8 years of experience in regulatory affairs, fluent English, and knowledge of GCC region regulations. This position offers competitive compensation and a flexible hybrid work model that balances on-site collaboration with autonomy.