Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client, a globally recognized pharmaceutical organization, is seeking an experienced Pharmaceutical Regulatory Affairs Specialist to join their dedicated team in Oxford . This crucial role involves managing regulatory submissions, ensuring compliance with health authority requirements, and supporting the lifecycle management of pharmaceutical products. You will work closely with R&D, clinical, and commercial teams to navigate the complex regulatory landscape and bring vital medicines to patients worldwide. This is an ideal position for a detail-oriented professional who thrives in a fast-paced, highly regulated environment.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for new drug applications (NDAs), variations, and annual reports to health authorities like the MHRA and EMA.
• Ensure all regulatory submissions and company activities comply with current pharmaceutical regulations and guidelines.
• Liaise with regulatory agencies, respond to queries, and manage interactions during regulatory reviews.
• Provide regulatory strategy input for product development programs and lifecycle management.
• Maintain an up-to-date understanding of global regulatory requirements and trends affecting the pharmaceutical industry.
• Collaborate with internal teams to ensure that labelling, promotional materials, and advertising comply with regulatory standards.

Requirements

• BSc or MSc in Pharmacy, Life Sciences, Chemistry, or a related discipline.
• Minimum of 4 years of experience in Regulatory Affairs within the pharmaceutical industry.
• Demonstrated experience in preparing and submitting regulatory dossiers (e.g., CTD format).
• Thorough understanding of global regulatory requirements, including ICH guidelines , GMP, and GxP.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to manage multiple projects simultaneously and work effectively under pressure.

Benefits

• Competitive annual salary and potential for performance bonuses.
• Comprehensive benefits package including health insurance, dental coverage, and a pension plan.
• Opportunities for professional development and continuous learning.
• A dynamic and international work environment within a leading pharmaceutical company.
• Supportive team culture focused on collaboration and regulatory excellence.