Regulatory Affairs Director

Regulatory Affairs Director - Oncology

Location: USA - Gaithersburg MD, Canada- Missisagua

Would you like to apply your Regulatory Affairs strategy expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines?

At AstraZeneca , we do this with the upmost integrity even in the most sophisticated situations because we are committed to doing the right thing! We continuously forge partnerships that help bring world-class treatments to patients in new ways, combining our people’s outstanding skills with those of people from all over the globe. Within Oncology Regulatory Science Strategy and Excellence (ORSSE), we bring hope and solutions to patients with unmet needs. We work across our ground-breaking pipeline and the business to get medicines to patients as efficiently and optimally as possible.

The Regulatory Affairs Director (RAD) provides strategic and operational regulatory leadership to the development, commercialization and life cycle management of assigned oncology products. Serves as the global regulatory lead (GRL) on early stage projects or specific indications of larger programs and/or as the regional regulatory lead. The RAD plays a substantial role crafting and implementing the clinical strategy and influencing health authorities to improve outcomes.

What you'll do:

• Lead cross functional teams in major regulatory submissions (NDA/BLA/IND/CTA), health authority interactions, label discussions, and securing approvals.

• Develop and implement the program's regional or global strategy ensuring that it is crafted to deliver rapid approval with competitive labeling that is identified by the business, markets and patients.

• Craft the health authority engagement strategy and interaction plan, drive the formulation of the briefing document focused on strategy and scientific content, lead the team through meeting rehearsals and moderate the meeting itself.

• 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. Mentor and provide performance feedback to members of your GRST.

• Deliver regulatory milestones on your team including an assessment of risks and mitigations, emerging data, and the probability of success. Lead preparation of the regulatory strategy document and target product labeling.

• Own the negotiations with health authorities and initiate and deliver key regulatory documents.

• Plan and construct the global dossier and core prescribing information including product maintenance, supply and compliance activities.

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

Minimum Qualifications:

• Bachelor’s degree in a science-related field such as life sciences, pharmacy, biomedical sciences, or a related discipline, with a minimum of 3 years’ experience in regulatory affairs, regulatory strategy, or drug development within the pharmaceutical or biotechnology industry.

• strong knowledge of global regulatory affairs in oncology, across both early and late-stage development, with experience supporting or shaping regulatory strategies for major submissions and health authority, primarily for FDA.

• Strong experience with filing of INDs, CTAs, NDAs, BLAs, lifecycle management activities, and regulatory pathways relevant to oncology products.

• demonstrated experience in regulatory drug development, including preparation for major health authority interactions, development of briefing documents, contribution to labeling strategy, and support for regulatory submission planning and execution.

• strong capability in strategic thinking, cross-functional leadership, regulatory risk assessment, problem solving, and stakeholder influence, along with excellent oral and written communication skills. The ability to work effectively in a global matrix environment, lead through complexity, and drive alignment across multiple functions is essential.

Preferred Qualifications:

• Advanced degree preferred.

• Experience in Hematology is preferred.

• Prior experience with phase 3 design including end of phase 2 health authority interactions.

• Contribution to a regulatory approval including leading response team and labeling negotiations.

• Knowledge and 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.

• Ability to work strategically within a business critical and high-profile development program.

• Critical thinking on current global regulatory science questions and good understanding of the corresponding scientific and clinical component.

Next Steps – Apply today!

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 follow all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

Competitive salary and benefits package on offer:

Recognizing the importance of individualized flexibility, our ways of working allow employees to balance personal and work commitments while ensuring we continue to create a strong culture of collaboration and teamwork by engaging face-to-face in our offices 3 days a week. 

The annual base salary for this position ranges from $178,534 - 267,801. However, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles) or to receive a retirement contribution (hourly roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit

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Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.