Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client is seeking a knowledgeable and proactive Regulatory Affairs Specialist to support their pharmaceutical product portfolio from their Bradford office. This role is essential for navigating the complex landscape of pharmaceutical regulations, ensuring that our client's products meet all necessary compliance requirements for market approval and maintenance across various global territories. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying informed about evolving regulatory policies. This is a challenging and rewarding position for an individual passionate about ensuring patient access to safe and effective medicines.

Key Responsibilities

• Prepare, review, and submit regulatory dossiers (e.g., CTD, NDA, MAA) to health authorities worldwide.
• Maintain product registrations and ensure ongoing compliance with relevant regulations and guidelines.
• Liaise directly with regulatory agencies to respond to queries and facilitate the approval process.
• Monitor changes in the global regulatory environment and assess their impact on the company's products and strategies.
• Collaborate with internal departments (R&D, Manufacturing, Marketing) to ensure regulatory requirements are met throughout the product lifecycle.
• Review promotional materials and labeling for regulatory compliance.

Requirements

• Bachelor's degree in Pharmacy, Life Sciences, or a related discipline; advanced degree is a plus.
• Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry.
• Strong understanding of international pharmaceutical regulatory requirements (e.g., FDA, EMA, MHRA).
• Experience with regulatory submission software and databases.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects and meet tight deadlines.

Benefits

• Competitive salary and annual bonus opportunities.
• Comprehensive health, dental, and vision insurance.
• Generous pension plan and life assurance.
• Paid time off and public holiday allowance.
• Opportunities for professional development and international travel.