Associate Director, EU Regulatory Lead Global Regulatory Affairs Development Strategy
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion AstraZeneca Rare Disease, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
Developing and implementing EU regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs.
Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
You will be responsible for:
- Developing innovative and effective EU regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.
- Preparing and executing local aspects of regional regulatory affairs, and ensuring integration into global regulatory strategy.
- May act as Global regulatory lead (GRL) on assigned programs. As GRL, acting as primary regulatory contact for associated Global Development Team and leading Regulatory Sub team (RST) for the program.
- Providing advice on regulatory issues for pipeline products; actively collaborating with management 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.).
- Representing Alexion as point contact with regional health authority and leading regulatory meetings. Supervising junior regulatory staff to provide support for and coordination of regulatory meetings and information package development.
- Coordinating submissions to authorities in support of proposed and ongoing development programs, e.g., new clinical trial submissions, new marketing authorisation applications, etc.
- Monitoring the development of new regulatory requirements or guidance documents and advising product teams of the impact on the business or development programs.
- Ensuring exemplary behavior, ethics and transparency within the company and with regulatory agencies
You will need to have:
- Bachelor’s Degree in a related field.
- Strong knowledge of drug development and regulatory policy; excellent scientific and business judgment.
- Experience providing strategic regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds.
- Ability to manage complex issues and coordinate multiple projects simultaneously.
- Ability to build intra-team relationships and collaborate in a distributed 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.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Good English oral and written communication skills
- Ability to work in a flexible environment to meet all regulatory requirements and business requirements
- Experience with orphan developments in development setting
- Experience leading regulatory interactions
- Good organizational skills
- Some travel might be required
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
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.