Associate Regulatory Affairs Director

The Associate Regulatory Affairs Director (RAD), 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: 

• Accountable for the regulatory execution of submissions in the relevant regulatory jurisdiction(s), by actively collaborating with other Regulatory functions and cross-functional teams (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, paediatric submissions, etc.). 

•  Actively be up to date on latest regulatory requirements and trends, and contribute to the shaping of the regulatory science environment. Support regulatory intelligence and policy priorities based on Alexion and AstraZeneca’s internal knowledge and expertise.  
• Supports relevant internal activities, including development and management of select Regulatory processes and procedures, as well as inspection/audit support. 
• Demonstrate strategic leadership skills contributing to effective product development. Provide team leadership and participate in mentoring, and performance feedback to regulatory and cross-functional colleagues. 
• Ensure exemplary behavior, leadership, ethics and transparency within the Enteprise, with Health Authorities and other external stakeholders. 

Qualifications:

• Bachelor’s Degree, life science

• ​Postgraduate degrees relevant to the role (e.g. MSc, PhD, PharmD, MD) a plus

• 7+ years of relevant Regulatory experience in the pharmaceutical industry, with experience in regional regulatory strategies (e.g. EU, US, UK, Canada). 

• Strong knowledge of drug development and regulatory environment, coupled by excellent scientific and business judgment. 

• Experience providing strategic regulatory advice in at least one several regulatory jurisdiction(s) (e.g. EU, US, Canada, UK) for the global development of products through most stages of development including pre-approval and marketed assets. 

• Ability to manage complex issues and lead multiple projects simultaneously in a time-s