Pharmaceutical Regulatory Affairs Manager

About the Role

Our client, a significant contributor to the pharmaceutical landscape , is seeking a seasoned Pharmaceutical Regulatory Affairs Manager to oversee regulatory strategies and submissions in Sunderland . This hybrid role requires a strategic thinker with a deep understanding of global regulatory requirements to ensure timely approval and compliance of pharmaceutical products. You will lead a team, interact with health authorities, and shape the regulatory path for innovative medicines. This is a crucial leadership position within a company committed to bringing essential treatments to patients worldwide, based in the heart of Sunderland .

Key Responsibilities

• Develop and implement global regulatory strategies for new and existing pharmaceutical products.
• Prepare, submit, and manage regulatory dossiers to health authorities (e.g., MHRA, EMA, FDA).
• Ensure compliance with all applicable national and international pharmaceutical regulations and guidelines.
• Lead and mentor a team of regulatory affairs professionals, fostering their development and performance.
• Liaise with health authorities, respond to queries, and negotiate regulatory submissions.
• Monitor regulatory intelligence and advise the company on emerging trends and changes impacting the pharmaceutical industry .

Requirements

• Master's or Ph.D. in Pharmacy, Chemistry, Life Sciences, or a related field.
• Minimum of 7 years of progressive experience in pharmaceutical regulatory affairs.
• Proven success in managing regulatory submissions and achieving product approvals in major markets.
• Extensive knowledge of regulatory requirements for drug development, manufacturing, and marketing.
• Experience in leading cross-functional teams and interacting with health authorities.
• Excellent strategic thinking, communication, and negotiation skills.

Benefits

• Highly competitive salary and executive bonus structure.
• Hybrid work arrangement promoting work-life balance.
• Comprehensive executive health, dental, and vision benefits.
• Generous long-term incentive plan and company pension.
• Significant opportunities for career advancement within the pharmaceutical sector.