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Director, Global Regulatory Affairs, Development Strategy

Location Boston, Massachusetts, United States Gaithersburg, Maryland, United States Job ID R-185030 Date posted 12/02/2024

This is what you will do:

Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. 

You will be responsible for:

  • Develops and directs innovative and effective regulatory strategies in support of specific projects, and across projects in the Alexion portfolio.
  • Serve as US Strategy lead on assigned programs. Acts as submission sub-team lead for US submissions and is core member of Regulatory Subteam (RST) for assigned programs.
  • Provides advice on regulatory issues for both marketed and 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.).
  • Accountable for preparation and execution of regional aspects of the regulatory global strategy. Can include setting direction for junior staff to execute regional regulatory tasks according to strategy.
  • Represents Alexion as point contact FDA and leads Alexion delegation for regulatory authority meetings. 
  • Lead US submissions to regulatory authorities in support of proposed and ongoing development programs, e.g., new clinical trial protocols, new marketing authorisation applications, etc. 
  • Monitors the development of new regulatory requirements or guidance documents and advises 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.
  • Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies.

You will need to have:

[Definition: Essential Qualifications. The minimum skills and requirements needed for the position]

Qualifications

  • 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 all stages of development including pre-approval and marketed compounds.
  • Experience with leading major submissions and FDA meetings
  • 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.

Education

  • Bachelor’s Degree in a related discipline   
  • 12 years in pharmaceutical industry regulatory affairs

Competences

  • Ensures Accountability
  • Collaborates
  • Decision Quality
  • Cultivates Innovation
  • Being Resilient
  • Learning and Self-Development

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.

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