Associate Director Regulatory Affairs

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

This position is posted by Jobgether on behalf of a partner company. We are currently looking for an Associate Director Regulatory Affairs in UK.

In this role, you will play a key part in shaping and executing regulatory strategies across the EMEA region for innovative therapies addressing rare diseases. You will operate in a dynamic, science-driven environment, working closely with cross-functional teams to support late-stage development, global clinical trials, and post-marketing activities. Your expertise will directly influence regulatory success, patient access, and long-term product sustainability. This position offers a balance of strategic leadership and hands‑on execution within a collaborative and mission-driven setting. You will engage with global and regional stakeholders while navigating complex regulatory frameworks. The role follows a flexible hybrid work model, combining on-site collaboration with autonomy.

Accountabilities:

• Define, contribute to, and execute EMEA regulatory strategies for assigned products across development and post-marketing phases
• Provide strategic and technical regulatory guidance to cross-functional development and project teams
• Review and contribute to regulatory documentation, including major submissions such as INDs, NDAs, BLAs, and MAAs
• Coordinate and manage regulatory sections of global applications and support label development activities
• Act as a primary or key liaison with regulatory agencies, including planning, preparing, and leading agency meetings
• Lead regulatory response processes and track post-marketing commitments and requirements
• Ensure effective coordination between global and local regulatory partners to meet regional objectives

Requirements:

• Bachelor’s degree in life sciences or a related field; an advanced degree is preferred
• Minimum of 8 years of experience in regulatory affairs within the pharmaceutical or biotech industry
• Strong knowledge of global regulatory frameworks, drug development processes, and post-approval requirements
• Proven experience with EMEA regulations, including drugs, biologics, and advanced therapy medicinal products
• Specific regulatory experience related to the GCC region is required
• Excellent communication, collaboration, and stakeholder management skills
• Fluency in English; Arabic is a strong advantage
• Willingness to travel occasionally, generally less than 10 percent

Benefits:

• Competitive compensation and long-term incentive opportunities
• Generous vacation allowance and company-observed public holidays
• Flexible hybrid work model with on-site collaboration days
• Comprehensive employee wellbeing and healthcare-related benefits
• Fitness reimbursement and wellness support programs
• Tuition sponsorship and structured professional development plans
• Opportunities to contribute to meaningful, patient-focused innovation

Why Apply Through Jobgether?

We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.

We appreciate your interest and wish you the best!

Data Privacy Notice: By submitting your application, you acknowledge that Jobgether will process your personal data to evaluate your candidacy and share relevant information with the hiring employer. This processing is based on legitimate interest and pre-contractual measures under applicable data protection laws (including GDPR). You may exercise your rights (access, rectification, erasure, objection) at any time.