Senior Regulatory Affairs Specialist

About the Role

Our client is looking for a knowledgeable and strategic Senior Regulatory Affairs Specialist to join their compliance team in Bradford . This role is essential for ensuring that all pharmaceutical products meet the rigorous regulatory requirements for market approval and ongoing compliance across various global territories. You will be responsible for preparing and submitting regulatory dossiers, interpreting complex regulations, and advising internal stakeholders on regulatory strategy. This is a significant opportunity for a dedicated regulatory professional to contribute to bringing vital medicines to patients worldwide and ensuring the company's operations remain compliant.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, MAA) for new drug applications and variations.
• Interpret and communicate regulatory requirements and guidelines to internal teams, including R&D, manufacturing, and marketing.
• Develop and implement regulatory strategies to support product development and lifecycle management.
• Maintain up-to-date knowledge of global pharmaceutical regulations and guidelines.
• Act as a primary contact with regulatory authorities, responding to queries and managing submissions.
• Ensure labeling and promotional materials comply with all applicable regulations.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Biology, or a related life science field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.
• Proven experience in preparing and submitting regulatory filings in key markets (e.g., UK, EU, US).
• Strong understanding of pharmaceutical development, manufacturing, and quality assurance principles.
• Excellent analytical, written, and verbal communication skills.
• Ability to manage multiple projects and deadlines effectively.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive health insurance, including medical, dental, and vision coverage.
• Generous holiday entitlement and company pension scheme.
• Professional development programs and opportunities for growth.
• Collaborative and supportive work environment within a leading pharmaceutical company.