Regulatory Affairs Manager

About the Role

Our client is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory submissions and compliance efforts in Southampton . This vital role involves developing and implementing regulatory strategies to ensure timely approval and market access for new pharmaceutical products. You will work closely with R&D, clinical, and commercial teams to navigate complex regulatory landscapes across global markets. This is a key leadership position for a seasoned regulatory professional who is passionate about bringing innovative medicines to patients, contributing to the company's growth and success within the thriving pharmaceutical hub of Hampshire .

Key Responsibilities

• Develop and execute global regulatory strategies for product development and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., INDs, NDAs, MAAs) to health authorities worldwide.
• Ensure compliance with all applicable national and international regulatory requirements.
• Serve as the primary point of contact for regulatory agencies during submissions and inspections.
• Provide regulatory guidance and support to project teams across the organization.
• Stay current with evolving regulatory guidelines and advise the company on potential impacts.

Requirements

• Bachelor's degree in a scientific discipline; advanced degree preferred.
• Minimum of 8 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated success in managing regulatory submissions and interactions with health authorities.
• In-depth knowledge of regulatory requirements in major markets (e.g., US, EU, UK).
• Excellent strategic thinking, communication, and leadership skills.
• Experience in a broad range of pharmaceutical product types and development stages.

Benefits

• Competitive salary and significant bonus opportunities.
• Comprehensive health, dental, and pension plans.
• Generous holiday allowance and company-related benefits.
• Opportunities for professional development and leadership training.
• A dynamic and collaborative office environment focused on innovation and patient outcomes.