Senior Regulatory Affairs Director

23 Sep, 2020


Senior Regulatory Affairs Director

Gaithersburg, MD

Do you have extensive expertise in regulatory drug development and proven strategic leadership skills? Would you like to apply your knowledge and competence to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.

We are now looking for passionate colleagues to join our team as Senior Regulatory Affairs Director.

The role can be based at either of AstraZeneca’s R&D sites in Gothenburg (Sweden), Cambridge (UK) or Gaithersburg (US).

What you’ll do

In your role as a Senior Regulatory Affairs Director, you will play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Our teams, within Regulatory Affairs (RA), define the regulatory strategy for our innovative pipeline, influence the development of our therapeutic assets and execute against the health authority engagement and submission plan globally. We thereby transform exciting science into valued new medicines and ensure that patients around the world can access our medicine.

Your main accountabilities/responsibilities:

As the Senior Regulatory Affairs Director, you will:

  • be accountable for leading the development and implementation of the global regulatory strategy for a product/group of products of increasing complexity. You will ensure that the strategy is designed to deliver rapid approval with competitive labeling in keeping with the properties of the product(s) and the needs identified by the business, markets and patients.
  • lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team.
  • lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities. You are comfortable speaking the regulatory voice at all levels of the organization.
  • be accountable for the delivery of all regulatory milestones on your team including assessment of the probability of regulatory success based on a thorough assessment of regulatory risks and mitigations. You will lead preparation of the regulatory strategy document and target product labeling.
  • show strategic leadership skills thereby contributing to effective product development. You will provide team leadership and participate in coaching and performance feedback to members of your GRST.
  • embrace the concept of sharing your experience with others so that the medicines that we develop will benefit from the latest approaches in regulatory science. You will also need your deep understanding of global regulatory science and your knowledge to integrate it with project strategy. You have a standing experience of overall drug/biologic development processes and strategies for high profile, complex or novel development programs.
  • ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams. The role also includes accountability for product maintenance, supply and compliance activities associated with marketed brands and partner with marketing companies (countries).

Essential for the role

  • Demonstrated competencies of strategic thinking, strategic influencing, innovation, initiative, leadership and excellent oral and written communication skills.
  • Advanced degree in a science related field and/or other appropriate knowledge/experience.
  • 7 – 10 years’ experience of regulatory drug development including product approval/launch. Successful leadership to at least one major regulatory approval at a global level including leading response team and labeling negotiations is desired.
  • Previous experience in leading major Health Authority interactions. Previous experience with FDA advisory committee and EMA oral explanation would be a plus.
  • A solid knowledge of regulatory affairs within several therapeutic areas in early and late development.
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs. Experience in relevant therapy area (small molecules & biologics) is preferred.
  • Proven leadership experience.
  • Ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable for the role

  • Previous experience working on due diligence activities and in a business alliance environment.
  • Ability to work strategically within a complex, business critical and high-profile development program.
  • Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical components.

So, what’s next?

Are you already imagining yourself joining us? Good, because we can’t wait to hear from you!

Welcome with your application; CV and cover letter, no later than October 31st , 2020.

Where can I find out more?

Our Gothenburg site:

Life in Gothenburg:

Culture and atmosphere of the Gothenburg site:


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 authorisation and employment eligibility verification requirements.

Learn more here

Job posted: 2020-09-23