Senior Pharmaceutical Regulatory Affairs Specialist

About the Role

Our client is seeking a highly experienced and knowledgeable Senior Pharmaceutical Regulatory Affairs Specialist to join their team in Glasgow . This critical role ensures that all of our client's pharmaceutical products comply with national and international regulatory standards throughout their lifecycle. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and providing strategic regulatory guidance to development and commercial teams. This hybrid position requires a proactive individual who can manage complex regulatory projects while ensuring timely approvals and maintaining compliance.

Key Responsibilities

• Prepare, review, and submit regulatory submissions (e.g., NDAs, MAAs, variations) to health authorities worldwide.
• Interpret and advise on global regulatory requirements, guidelines, and trends relevant to pharmaceutical products.
• Liaise with regulatory agencies during the submission and review process, addressing queries and facilitating communication.
• Develop and implement regulatory strategies to support product development, registration, and lifecycle management.
• Ensure compliance with relevant regulations and guidelines across all stages of product development and commercialization.
• Provide regulatory input and support for product labeling, advertising, and promotional materials.

Requirements

• Bachelor's or Master's degree in Pharmacy, Life Sciences, or a related field.
• Minimum of 6 years of progressive experience in pharmaceutical regulatory affairs.
• Demonstrated success in preparing and managing major regulatory submissions.
• In-depth knowledge of global regulatory frameworks (e.g., FDA, EMA, MHRA).
• Excellent written and verbal communication skills, with strong negotiation and influencing abilities.
• Ability to manage multiple projects simultaneously in a complex and evolving regulatory landscape.

Benefits

• Competitive salary and attractive bonus scheme.
• Comprehensive health, dental, and life insurance coverage.
• Generous holiday allowance and company pension plan.
• Hybrid working model providing work-life balance.
• Significant opportunities for professional growth and international exposure.