Regulatory Affairs Specialist - Pharmaceuticals

About the Role

Our client, a dynamic pharmaceutical company, is looking for a detail-oriented Regulatory Affairs Specialist to join their compliance team in Sunderland . This role is crucial for ensuring that the company's products meet all necessary regulatory standards for market approval and ongoing compliance across various geographies. You will be responsible for preparing and submitting regulatory documentation and liaising with health authorities. This is an excellent opportunity for a proactive individual to make a significant contribution to the successful market access of innovative pharmaceutical products, working within a collaborative and growth-oriented environment.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., MAA, NDA, variations) to health authorities in key markets.
• Ensure ongoing compliance with national and international pharmaceutical regulations and guidelines.
• Maintain regulatory documentation, databases, and submission archives.
• Liaise with internal departments (e.g., R&D, Quality, Manufacturing) to gather information for regulatory submissions.
• Monitor changes in the regulatory landscape and assess their impact on the company's products and strategies.
• Respond to queries from health authorities during the review process.

Requirements

• Bachelor's or Master's degree in Pharmacy, Chemistry, Biology, or a related field.
• 3-5 years of experience in regulatory affairs within the pharmaceutical industry.
• Solid understanding of global regulatory submission processes and guidelines (e.g., EMA, FDA).
• Experience with regulatory information management systems is a plus.
• 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.
• A hybrid work arrangement providing a blend of office and remote work flexibility.
• Comprehensive private medical and dental insurance.
• Generous holiday entitlement and company sick pay.
• Professional development support, including training and conference attendance to enhance regulatory expertise.