Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is looking for a detail-oriented and proactive Pharmaceutical Regulatory Affairs Specialist to join their team, working remotely from Bradford . You will be responsible for ensuring that the company's pharmaceutical products comply with all relevant national and international regulations throughout their lifecycle. This role involves preparing and submitting regulatory documentation, liaising with health authorities, and staying current with evolving regulatory landscapes. This is a key position for an experienced professional who excels in navigating complex regulatory environments and ensuring product compliance for market access.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., INDs, NDAs, MAAs ) to health authorities worldwide.
• Interpret and apply global regulatory guidelines and ensure compliance throughout product development and commercialization.
• Manage post-approval regulatory activities, including variations, renewals, and annual reports.
• Liaise with regulatory agencies, providing timely responses to queries and requests.
• Develop and maintain regulatory strategies for new product registrations and lifecycle management.
• Conduct regulatory intelligence activities to monitor changes in the regulatory environment and assess their impact.

Requirements

• Bachelor's degree in a scientific discipline, Law, or a related field. Master's degree preferred.
• Minimum of 4 years of experience in pharmaceutical regulatory affairs.
• Proven track record in preparing and submitting successful regulatory dossiers to major health authorities (e.g., FDA, EMA).
• Thorough understanding of drug development processes and relevant regulatory frameworks.
• Excellent analytical, problem-solving, and organizational skills.
• Strong written and verbal communication skills, particularly in drafting regulatory documents.

Benefits

• Competitive salary and performance-based bonus structure.
• Fully remote working environment with flexibility.
• Comprehensive health, dental, and vision insurance.
• Generous paid time off and holidays.
• Opportunities for professional development and international regulatory training.