Regulatory Affairs Specialist

About the Role

Our client has an exciting opening for a knowledgeable Regulatory Affairs Specialist to contribute to their regulatory compliance efforts in Leeds . This role is essential for navigating the complex landscape of pharmaceutical regulations, ensuring that all products meet the stringent requirements of global health authorities. You will be instrumental in preparing and submitting regulatory documentation, liaising with regulatory bodies, and advising internal teams on compliance strategies. This position offers a significant opportunity to shape regulatory pathways for innovative medicines in the West Yorkshire region.

Key Responsibilities

• Prepare, review, and submit regulatory filings (e.g., IND, NDA, MAA) to relevant health authorities.
• Maintain up-to-date knowledge of global regulatory requirements and guidelines.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Liaise directly with regulatory agencies during the review process and respond to queries.
• Ensure compliance with all approved labeling and promotional materials.

Requirements

• Bachelor's degree in a scientific or healthcare-related field; Master's or JD is a plus.
• Minimum of 3 years of experience in pharmaceutical regulatory affairs.
• Strong understanding of drug development processes and regulatory submission requirements.
• Proficiency in regulatory information management systems and submission software.
• Excellent written and verbal communication skills, with keen attention to detail.

Benefits

• Competitive salary and annual performance incentives.
• Flexible hybrid work arrangement to balance office and remote work.
• Comprehensive medical, dental, and vision benefits.
• Retirement savings plan with company contributions.
• Career advancement opportunities within a growing pharmaceutical company.