Regulatory Affairs Manager

About the Role

Our client is seeking an experienced and strategic Regulatory Affairs Manager to lead their regulatory operations, operating remotely across the UK. This pivotal role involves overseeing the regulatory strategy and execution for a portfolio of pharmaceutical products, ensuring compliance with global health authority requirements. You will be responsible for preparing and submitting regulatory dossiers, managing post-approval changes, and providing expert guidance to internal stakeholders. This is a fantastic opportunity for a seasoned regulatory professional to make a significant impact within a forward-thinking company that embraces remote work, offering substantial autonomy and the chance to shape regulatory pathways for innovative medicines from anywhere in the UK, contributing to global health initiatives.

Key Responsibilities

• Develop and implement global regulatory strategies for new product registrations and lifecycle management.
• Prepare, review, and submit regulatory dossiers (e.g., CTD, ANDA, NDA) to health authorities worldwide.
• Manage post-approval regulatory activities, including variations, annual reports, and safety updates.
• Liaise with regulatory agencies, ensuring timely and effective communication.
• Provide regulatory guidance and support to cross-functional teams, including R&D, manufacturing, and marketing.
• Monitor changes in the global regulatory landscape and assess their impact on the company's portfolio.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs .
• Proven track record of successful regulatory submissions and approvals in major markets (e.g., FDA, EMA).
• Comprehensive understanding of ICH guidelines and regional regulatory requirements.
• Strong strategic thinking and project management skills.
• Excellent written and verbal communication abilities, with a capacity for negotiation and influencing.

Benefits

• Highly competitive salary with an excellent bonus structure.
• Fully remote position offering maximum flexibility and work-life integration.
• Comprehensive private medical insurance and wellness programs.
• Generous pension scheme and paid time off.
• Significant opportunities for professional growth and leadership development within a growing organization.