Global Regulatory Affairs Strategy Director

3 weeks ago

Gaithersburg, United States AstraZeneca Full time

Are you a strategically focussed Regulatory professional and would like to play an integral part in bringing life changing Oncology medicines to patients? If you are please read on

About AstraZeneca

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.

Oncology Regulatory Science and Strategy

Within Oncology Regulatory Science and Strategy (ORSS) we bring hope and solutions to patients with unmet needs across the globe. As Regulatory professionals working on Oncology products, we work in areas of unmet need and take innovative regulatory approaches to bring life-changing treatments to patients. We work across our pipeline and the business to get medicines to patients as efficiently and effectively 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 labelling 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, Labelling 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 labelling.
  • 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.

Education, Qualifications, Skills and Experience

Essential for the role:

  • An advanced degree in a science related field and/or other appropriate knowledge/experience
  • A solid knowledge of regulatory affairs within at least one therapeutic area in early and late development
  • Previous demonstrated experience of regulatory drug development or equivalent, and experience with major HA interactions.
  • Demonstrated competencies of strategic thinking, strategic influencing, risk evaluation, innovation, initiative, leadership and excellent oral and written communication skills.
  • The ability to think strategically and critically and evaluate risks to regulatory activities.

Desirable for the role:

  • Experience in Oncology (small molecules & biologics)
  • Prior experience with phase 3 design including end of phase 2 health authority interactions
  • Contribution to a regulatory approval including leading response team and labelling 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.

Why AstraZeneca?

At AstraZeneca we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There’s no better place to make a difference to medicine, patients and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth and development. We’re on an exciting journey to pioneer the future of healthcare.

So, what’s next?

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

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 $173,600 to $260,401. 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 plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.

Where can I find out more?

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Date Posted

01-Oct-2024

Closing Date

29-Nov-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form. AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.

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