Head of International CMC Regulatory Affairs

A Strategic Leadership Opportunity in International CMC Regulatory Affairs at AstraZeneca

AstraZeneca presents a compelling opportunity for an experienced and dynamic leader to join their ranks as the Head of International CMC Regulatory Affairs (Executive Director). This pivotal role offers the chance to shape and drive regulatory strategy within one of the company's most significant and rapidly expanding regions. If you are a seasoned professional with a passion for regulatory excellence and a desire to make a tangible impact on global healthcare, this position warrants your close consideration.

What Makes This Opportunity Stand Out?

• Strategic Impact and Leadership: As the Head of International CMC Regulatory Affairs, you will hold significant accountability for the strategic direction and execution of CMC regulatory affairs across the entire product lifecycle for a vast and diverse international region. This includes over 75 markets, presenting a unique challenge and rewarding experience in navigating varied regulatory landscapes and cultural nuances.
• Team Leadership and Development: This role offers the chance to lead and mentor a substantial team, including Directors and a larger indirect team. Your ability to foster a high-performing, collaborative environment and develop talent will be crucial to success, aligning with AstraZeneca's commitment to building organizational capability.
• Driving Innovation and Collaboration: You will be instrumental in partnering with Research, Development, and Operations experts to craft innovative regulatory strategies for both current and future product portfolios. This includes influencing senior internal and external stakeholders, ensuring regulatory compliance, and contributing directly to the achievement of AstraZeneca's ambitious financial and business goals.
• Global Supply Chain Influence: A key aspect of this role involves collaborating with Operations Supply Chain leadership to optimize commercial supply chains. Your regulatory input will be vital in strategic decision-making for a broad portfolio of products, ensuring continuity of drug supply and operational efficiency.
• Working with a Robust Pipeline: AstraZeneca's commitment to innovation means you'll have the opportunity to work with a rich and robust pipeline of ground-breaking medicines across diverse therapy areas and at all stages of development. This provides a dynamic and engaging work environment for those driven by scientific advancement.
• A Global, Diverse Environment: The International region is the largest, most diverse, and fastest-growing at AstraZeneca, offering exposure to a multitude of cultures and languages. This provides an unparalleled opportunity for professional growth and understanding of global regulatory affairs.

Key Considerations for Your Career Path:

• Deep CMC Regulatory Expertise: A strong foundation in Regulatory Affairs, with a specific focus on CMC, is essential. Candidates with experience in CMC Development, Quality Control, Manufacturing, or within regulatory agencies will find this role a natural progression.
• Strategic Acumen and Influence: The ability to think strategically, influence at all levels, and navigate complex cross-functional and cross-cultural landscapes is paramount. This role demands a sophisticated approach to stakeholder management and decision-making.
• Proven Team Leadership: Extensive experience in leading and developing teams is a non-negotiable requirement. Your success will be measured by your ability to inspire and empower your direct and indirect reports.
• International Experience: Experience working within an international environment and demonstrating strong leadership, communication, and interpersonal skills in such settings will be highly valued.
• Change Management Aptitude: While desirable, experience in leading significant change programs can be a significant asset in this role, given the dynamic nature of global regulatory affairs and the growth of the international region.
• Contribution to Business Objectives: This role has a direct impact on AstraZeneca's success. Candidates who thrive on aligning regulatory strategy with broader business and financial goals will find this position particularly rewarding.

This position is based in Cambridge or Macclesfield, UK, and offers a competitive salary and excellent benefits. If you are a visionary leader ready to take on a role of substantial influence and contribute to bringing life-changing medicines to patients worldwide, this opportunity at AstraZeneca is one to seriously explore.