Associate Director, Regulatory Affairs US Lead, Regulatory Science & Execution

The Associate Regulatory Affairs Director, US Lead, Regulatory Science & Execution will be accountable for the development, implementation and maintenance of regulatory strategies for assigned project(s)/product(s) and regulatory jurisdiction(s), with the intention of achieving successful registration and lifecycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.  

This individual will provide tactical and strategic input to and leadership across regulatory and cross-functional teams with the objective of delivering according to regional and global Business Objectives. The individual will also ensure effective communication and constructive working relationships with business partners and representatives of regulatory authorities.  

You will be responsible for:  

• Working with manager to develop and direct innovative and effective regulatory strategies in support of assigned Alexion portfolio, pipeline and therapeutic areas. 
• Serving as US Strategy Lead on assigned programs. Acting as submission sub-team lead for US submissions and is core member of Global Regulatory Team (GRT) for assigned programs. 
• Providing advice on regulatory issues for pipeline products; actively collaborates with management, Global Regulatory Lead, and cross functional colleagues within Alexion (i.e., commercial, research, clinical development, medical affairs, business development, legal, manufacturing, quality, portfolio management, financial, human resources, etc.).  
• Preparing and executing US-specific aspects of regulatory affairs and ensures integration into global regulatory strategy. 
• Representing Alexion as point contact with FDA, including providing support for and coordination of regulatory meetings and information package development.
• Coordinating submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial application submissions, amendments, etc.   
• Monitoring the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs Provides support to regulatory affairs reviewers for due diligence initiatives, including opportunity and risk assessment. 
• Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies 

 
Minimum Qualifications:

• Bachelor's Degree in life science   
• Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus  
• Additional certification and/or training relevant to the role over the past
• 7 years in pharmaceutical industry regulatory affairs  
• Strong knowledge of US drug development and regulatory policy; excellent scientific and business judgment. 
• Experience providing US strategic regulatory advice for the global development of products through some stages of development. 
• Experience leading submissions and FDA meeting. 
• Ability to manage complex issues and coordinate multiple projects simultaneously. 
• Ability to build intra-team relationships and collaborate in a global team environment at all levels of the organization.   
• Strong interpersonal and written/verbal communication skills. 
• Proven track record practicing sound judgment as it relates to risk assessment 
• Highly conversant and knowledgeable of new and emerging regulations and guidances. Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information 

Working at AstraZeneca

Here you’ll have the chance to create a substantial difference to patients’ lives! With science at its heart, this is the place where breakthroughs born in the lab become transformative medicines – for the world’s most complex diseases. Answer unmet medical needs by pioneering the next wave of science, focusing on outcomes and crafting the patient ecosystem.

Next Steps? Apply now!

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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