Regulatory Affairs Manager reference: R-238290

Unlock Your Potential as a Regulatory Affairs Manager in Pancras Square

This permanent Regulatory Affairs Manager position at AstraZeneca presents a compelling opportunity for experienced professionals seeking to shape the regulatory landscape for life-saving medicines. Located in the vibrant Pancras Square, this role offers a platform to drive significant impact within a globally recognized pharmaceutical leader, renowned for its commitment to innovation and patient well-being.

Why This Role is a Career Catalyst:

• Strategic Impact: You will be at the forefront of developing and executing regulatory strategies for new initiatives and ensuring the timely delivery of critical clinical trial approvals in the UK. This is a chance to influence the direction of novel treatments and directly contribute to bringing them to patients.
• Comprehensive Product Lifecycle Management: The role encompasses the full lifecycle of licenses, from initial submission to ongoing maintenance, including CMC and labelling. This offers a holistic and in-depth understanding of regulatory processes across various stages of product development.
• Cross-Functional Collaboration: Success in this position hinges on seamless collaboration with diverse cross-functional teams. You will hone your business relationship management skills, navigating complex interactions to achieve shared goals.
• Building Key Relationships: A significant aspect of the role involves cultivating and maintaining strong, positive, and trustworthy relationships with local health authorities. This is a unique chance to leverage your scientific knowledge and negotiation skills to foster productive dialogue that benefits patients.
• Continuous Improvement and Optimization: You'll be instrumental in optimizing and continuously improving submission processes, applying global quality standards to ensure efficiency and compliance. This role encourages a proactive approach to regulatory excellence.
• Professional Development: AstraZeneca fosters a culture of learning and growth. This role provides exposure to evolving regulatory environments and opportunities to deepen your drug development knowledge, all within a supportive and ambitious setting.

Key Considerations for Your Career Path:

• Post-Brexit UK Regulatory Expertise is Crucial: A strong understanding of the post-Brexit UK regulatory framework is essential. Candidates with direct experience in this domain will find this role particularly rewarding.
• Commercial Acumen: This position requires more than just technical regulatory knowledge. You'll need to demonstrate commercial awareness and the ability to align regulatory strategies with business objectives, ensuring a competitive advantage.
• Negotiation and Influence: The ability to effectively negotiate with stakeholders, including health authorities, is a cornerstone of this role. Developing and applying strong negotiation and influencing skills will be key to your success.
• Adaptability and Change Management: The pharmaceutical industry is dynamic. Candidates who can effectively manage change, remain productive during periods of uncertainty, and proactively engage stakeholders will thrive.
• IT System Proficiency: Leveraging IT systems effectively is vital for efficient workflow and data management. Proficiency in relevant systems will enable you to optimize your contributions.
• Desirable Specialization: While not essential, experience in the Respiratory and Immunology (R&I) or Vaccines and Immune Therapies (V&I) therapy areas, and experience with Veeva systems, would be a distinct advantage, offering further avenues for specialization and impact.

This Regulatory Affairs Manager role at AstraZeneca is an exceptional opportunity for ambitious professionals to advance their careers within a company that is truly changing the practice of medicine. If you are passionate about regulatory excellence, strategic thinking, and making a tangible difference in the lives of patients, this position warrants your serious consideration.