Regulatory Affairs Manager

About the Role

Our client is seeking a seasoned Regulatory Affairs Manager to guide their regulatory strategies from their base in Southampton . This role is responsible for ensuring that all products meet the necessary regulatory requirements for marketing and sale across key global markets. You will lead the preparation and submission of regulatory dossiers, liaise with health authorities, and provide expert advice on evolving regulatory landscapes. This is a crucial position for ensuring compliance and facilitating market access for the company's innovative pharmaceutical products.

Key Responsibilities

• Develop and implement global regulatory strategies for product registration and lifecycle management.
• Prepare, review, and submit regulatory applications (e.g., CTAs, MAAs, NDAs) to health authorities worldwide.
• Serve as the primary contact for regulatory agencies, managing communications and addressing queries.
• Monitor and interpret changes in the global regulatory environment and assess their impact on the company's products.
• Ensure all labeling, advertising, and promotional materials comply with regulatory requirements.
• Provide regulatory guidance and support to project teams throughout the product development lifecycle.

Requirements

• Bachelor's or Master's degree in a relevant scientific discipline (e.g., Pharmacy, Chemistry, Biology).
• Minimum of 8 years of experience in Regulatory Affairs within the pharmaceutical or biotech industry.
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., EU, US).
• Comprehensive knowledge of international pharmaceutical regulations and guidelines (e.g., ICH, FDA, EMA).
• Excellent communication, negotiation, and project management skills, with strong attention to detail.

Benefits

• Competitive salary and comprehensive bonus program.
• Remote working flexibility for a better work-life balance.
• Extensive health, dental, and vision insurance coverage.
• Generous annual leave and paid time off.
• Professional development opportunities and international travel for conferences and meetings.