Senior Regulatory Affairs Specialist

About the Role

Our client, a dynamic pharmaceutical company, is seeking a meticulous and experienced Senior Regulatory Affairs Specialist to join their team in Leeds . This role is critical for ensuring that the company's pharmaceutical products meet all necessary regulatory requirements for development, approval, and marketing across various global markets. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving regulatory landscapes. This is an excellent opportunity for a seasoned regulatory professional to contribute to the company's growth and success in bringing innovative medicines to patients.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTAs, MAAs, NDAs) to health authorities worldwide.
• Interpret and advise on regulatory requirements and guidelines for product development and lifecycle management.
• Serve as the primary regulatory contact for assigned projects and products, liaising with internal teams and external partners.
• Monitor regulatory changes and assess their impact on company products and strategies.
• Develop and maintain regulatory strategies to support product approvals and market access.
• Ensure compliance with all applicable regulations and internal company policies throughout the product lifecycle.

Requirements

• Bachelor's or Master's degree in pharmacy, chemistry, biology, or a related scientific field.
• Minimum of 5 years of hands-on experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting various types of regulatory applications.
• In-depth knowledge of international regulatory requirements (e.g., FDA, EMA, ICH).
• Strong analytical skills and the ability to assess complex regulatory issues.
• Excellent written and verbal communication skills, with strong attention to detail.

Benefits

• Competitive salary and annual bonus opportunities.
• Comprehensive health, dental, and vision insurance coverage.
• Generous paid time off and a company-matched pension scheme.
• Support for continuous professional development and training in regulatory affairs.
• A collaborative and innovative work environment with opportunities for career progression.