Regulatory Affairs Manager

About the Role

Our client is seeking an accomplished and strategic Regulatory Affairs Manager to lead their regulatory submissions and compliance efforts, supporting operations in Leeds from a fully remote capacity. This role is pivotal in navigating the complex global regulatory landscape for pharmaceutical products, ensuring timely approvals and market access. You will be responsible for developing and executing regulatory strategies, preparing submission dossiers, and liaising with health authorities worldwide. This remote position is ideal for a seasoned regulatory professional seeking to make a significant impact on a global scale without the need for physical office presence.

Key Responsibilities

• Develop and implement comprehensive regulatory strategies for product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTAs, MAAs, NDAs) to health authorities globally.
• Serve as the primary point of contact for regulatory agencies, responding to inquiries and managing communications.
• Ensure compliance with all applicable national and international regulations and guidelines.
• Monitor changes in the regulatory environment and assess their impact on the company's products and strategies.
• Provide regulatory guidance and support to internal teams, including R&D, marketing, and manufacturing.

Requirements

• Master's degree or PhD in a scientific, pharmaceutical, or related field.
• Extensive experience (7+ years) in pharmaceutical regulatory affairs, with a strong understanding of global submission requirements.
• Proven success in managing complex regulatory submissions and achieving timely approvals.
• Expertise in relevant regulatory guidelines (e.g., ICH, FDA, EMA, MHRA).
• Exceptional communication, negotiation, and leadership skills.
• Demonstrated ability to work autonomously and manage multiple projects effectively in a remote environment.

Benefits

• Highly competitive executive salary and bonus structure.
• Comprehensive health, dental, and vision coverage.
• Generous stock options or equity package.
• Significant professional development budget and opportunities to attend international conferences.
• Full remote work flexibility, allowing you to work from anywhere within your home country.