Regulatory Affairs Specialist

About the Role

Our client, a dynamic and forward-thinking pharmaceutical company , is looking for a detail-oriented Regulatory Affairs Specialist to join their team in Sunderland . This role is crucial for ensuring that all products meet the stringent requirements set by regulatory bodies across various markets. You will be instrumental in preparing and submitting regulatory dossiers, managing product registrations, and maintaining compliance throughout the product lifecycle. This position offers an excellent opportunity to contribute to the global accessibility of innovative pharmaceutical products and to grow your career within a supportive and expert regulatory affairs department.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new product applications and variations in accordance with relevant guidelines (e.g., EMA, FDA).
• Manage and maintain product registrations and licenses in assigned territories.
• Liaise with regulatory authorities to address queries and facilitate the approval process.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Collaborate with internal departments, including R&D, Quality Assurance, and Marketing, to ensure regulatory compliance.
• Develop and implement regulatory strategies to support product development and commercialization goals.

Requirements

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or a related discipline.
• Minimum of 3 years of experience in Regulatory Affairs within the pharmaceutical industry .
• Solid understanding of global regulatory submission requirements and guidelines.
• Experience with Common Technical Document (CTD) preparation and submission.
• Excellent attention to detail, organizational skills, and ability to manage multiple projects simultaneously.
• Proficiency in regulatory information management systems and relevant software.

Benefits

• Competitive salary package with performance-related incentives.
• Comprehensive health and wellness benefits, including medical, dental, and vision coverage.
• Company pension scheme and life insurance.
• Flexible hybrid working arrangements to promote work-life balance.
• Opportunities for professional development and further training in regulatory sciences.
• A collaborative work environment where innovation and expertise are valued.