Do you have extensive expertise in regulatory drug development? Would you like to be accountable for leading the development and implementation of regulatory strategies? 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 a passionate colleague to join our team as Regulatory Affairs Director.

The role is based at AstraZeneca’s R&D site in Gaithersburg (US).

What you’ll do

In the role as a 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 Regulatory Affairs Director, you will:

• be accountable for leading the development and implementation of the regional or global regulatory strategy for a product/group of products. 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. This includes an health authority engagement strategy and considerations of expedited regulatory programs.

• 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.

• 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.

• be accountable for initiating and delivering key regulatory documents and plans and leading the negotiations with health authorities.

• lead the objective assessment of emerging data against aspirations and update senior management on project risks/mitigation activities.

• be willing to learn from your peers and be actively engaged in peer learning sessions so that the medicines that we develop incorporate the latest approaches in regulatory science. You embrace the concept of novel regulatory tools and technology.

• ensure appropriate planning and construction of the global dossier and core prescribing information led by the respective teams.  The role includes being accountable for product maintenance, supply and compliance activities associated with marketed brands.

• partner with marketing companies (countries) and regional regulatory affairs staff to influence developing views/guidance.

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.

• At least 5-year experience of regulatory drug development or equivalent, and experience with major Health Authority interactions. Prior experience with phase 3 design including end of phase 2 health authority interactions is desired. Contribution to a regulatory approval including leading response team and labeling negotiations would be a plus.

• A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development.

• Proven leadership experience.

• The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable for the role

• Good understanding of guiding principles in drug development such as benefit/risk profile, dose selection or statistical design.

• 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).

• 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 21st , 2020!

Date Posted

Closing Date

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.