Senior Regulatory Affairs Manager

About the Role

Our client is seeking a strategic and experienced Senior Regulatory Affairs Manager to oversee regulatory submissions and strategy for their innovative pharmaceutical products. Based in Manchester , you will play a crucial role in navigating the complex regulatory landscape, ensuring timely approvals and maintaining compliance across key markets. This position offers the chance to work on exciting new drug candidates and collaborate with a dedicated team of professionals committed to bringing life-changing medicines to patients. The role involves a blend of remote and office-based work, offering flexibility while maintaining close team cohesion.

Key Responsibilities

• Develop and execute regulatory strategies for product development and lifecycle management, from early phase to post-approval.
• Prepare, review, and submit regulatory dossiers to health authorities (e.g., MHRA, EMA, FDA).
• Liaise effectively with regulatory agencies, responding to queries and negotiating submission requirements.
• Provide expert regulatory guidance to project teams, ensuring product development aligns with global compliance standards.
• Monitor and interpret evolving regulatory guidelines and advise the organization on potential impacts and opportunities.

Requirements

• Bachelor's or Master's degree in a relevant scientific or technical field.
• Significant experience (8+ years) in regulatory affairs within the pharmaceutical or biotechnology industry.
• Proven track record of successful regulatory submissions and interactions with health authorities.
• Deep understanding of drug development processes and global regulatory requirements.
• Excellent strategic thinking, problem-solving, and interpersonal communication skills.

Benefits

• A highly competitive salary commensurate with experience.
• Comprehensive health, dental, and vision insurance plans.
• Generous annual leave and company holidays.
• Opportunities for professional growth, training, and international conference participation.
• A hybrid working model providing a balance between remote flexibility and in-office collaboration in Manchester .