Senior Regulatory Affairs Specialist (Pharmaceutical)

About the Role

Our client is looking for an accomplished Senior Regulatory Affairs Specialist to lead regulatory strategy for their pharmaceutical products in Edinburgh . This vital role involves ensuring compliance with global regulatory requirements for product registration, maintenance, and lifecycle management. You will liaise with regulatory authorities, develop submission strategies, and provide expert guidance to internal teams. This is an excellent opportunity to shape regulatory pathways and contribute to bringing innovative therapies to patients worldwide from a key UK hub.

Key Responsibilities

• Develop and implement global regulatory strategies for new drug applications (NDAs) and marketing authorization applications (MAAs).
• Prepare, review, and submit regulatory dossiers to health authorities worldwide (e.g., MHRA, FDA, EMA).
• Serve as the primary point of contact for regulatory agencies during reviews and inquiries.
• Provide expert interpretation and guidance on evolving global regulatory requirements.
• Collaborate with R&D, clinical, manufacturing, and marketing teams to ensure regulatory compliance.
• Manage post-approval regulatory activities, including variations, renewals, and safety reporting.

Requirements

• Bachelor's degree in a life science, pharmacy, or related field; advanced degree preferred.
• Minimum of 7 years of experience in pharmaceutical regulatory affairs.
• Extensive knowledge of global regulatory submission processes and requirements.
• Proven track record of successful regulatory submissions and approvals.
• Excellent analytical, strategic thinking, and communication skills.
• Ability to manage complex projects and lead cross-functional regulatory initiatives.

Benefits

• Highly competitive salary and executive benefits package.
• Significant opportunities for leadership and career advancement.
• Exposure to a diverse portfolio of innovative pharmaceutical products.
• Work in a dynamic and growth-oriented company based in Edinburgh .
• Contribute to improving global health outcomes through regulatory expertise.