Associate Director Regulatory Affairs

Info Resume Edge; Leeds; On-site; GBP 85,000 - 120,000; Full time

Job summary

A leading global regulatory affairs firm is seeking an Associate Director Regulatory Affairs to lead regulatory compliance and oversee product registrations. This role involves collaborating with cross-functional teams and ensuring adherence to FDA regulations and EMA guidelines. The ideal candidate has over 8 years of regulatory affairs experience and a strong academic background in a related field. This position offers a competitive salary and an executive benefits package.

Benefits

Competitive salary and executive benefits package

Leadership role in regulatory strategy and compliance

Exposure to global regulatory affairs projects

Qualifications

• 8+ years of experience in regulatory affairs, including leadership roles.
• Strong knowledge of regulatory submissions, product labeling, and compliance processes.
• Ability to work in a fast-paced, deadline-driven environment.

Responsibilities

• Lead the preparation and review of regulatory submissions for product approvals.
• Ensure ongoing regulatory compliance with applicable laws, guidelines, and standards.
• Develop regulatory strategies to support new product development and market expansion.

Skills

Regulatory submissions

Leadership

Communication

Project management

Education

Bachelor's or advanced degree in Pharmacy, Life Sciences, or related field

Job description

Overview

Associate Director Regulatory Affairs to lead and oversee regulatory compliance, product registration, and regulatory submissions across multiple markets. The role ensures that products meet FDA regulations, EMA guidelines, and other international regulatory standards while supporting strategic business objectives.

Key Responsibilities

• Lead the preparation and review of regulatory submissions for product approvals.
• Ensure ongoing regulatory compliance with applicable laws, guidelines, and standards.
• Develop regulatory strategies to support new product development and market expansion.
• Collaborate with cross-functional teams on clinical trials and quality assurance requirements.
• Maintain up-to-date knowledge of FDA regulations, EMA guidelines, and other global regulatory requirements.
• Represent the company in communications with regulatory agencies.

Requirements

• Bachelor's or advanced degree in Pharmacy, Life Sciences, or related field.
• 8+ years of experience in regulatory affairs, including leadership roles.
• Strong knowledge of regulatory submissions, product labeling, and compliance processes.
• Excellent leadership, communication, and project management skills.
• Ability to work in a fast-paced, deadline-driven environment.

Benefits

• Competitive salary and executive benefits package.
• Leadership role in regulatory strategy and compliance.
• Exposure to global regulatory affairs projects and innovations.

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