Associate Regulatory Affairs Director, Oncology
Would you like to apply your Regulatory Affairs 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 difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
Gaithersburg is one of over 400 sites here at AstraZeneca, providing a collaborative environment where everyone feels comfortable and able to be themselves is at the core of AstraZeneca’s priorities, it’s meaningful to us that you bring your full self to work every day. This site includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center, game rooms, community garden and more to keep our employees happy and balanced! This modern and vibrant scientific campus is the home of R&D and Oncology in the US.
The Associate Regulatory Affairs Director (ARAD) position is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. This role is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading applications and managing procedures through approval.
The ARAD provides expertise and mentorship on procedural and documentation requirements to Global Regulatory Execution Team (GRET), Global Regulatory Strategy Team (GRST) and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
What you'll do:
- Understand the regulatory framework, including regional trends for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory expertise as defined by Health Authorities for assigned deliverable(s) including: submission delivery strategy, review documents, provide input, analyze regulatory procedure and special designations, and share best practices for process improvement in a dynamic environment.
- Lead and contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle.
- Lead GRST & GRET sub-teams for major submissions (NDA/MAA or major LCM initiative).
- Develop, implement and maintain submission delivery and content plans and proactively provide status updates to designated partners.
- Coordinate the input, maintenance and revision in the PLANIT project plans for assigned projects and highlight unforeseen changes in resource demand in a timely manner.
- Identify regulatory risks and communicate mitigations to Lead Regulatory Project Manager (LRPM) and cross functional teams.
- Support operational and compliance activities for assigned deliverables.
- May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
- Provide coaching, mentoring and knowledge sharing within the team.
- BS/MS Degree in Science or related field
- Extensive regulatory experience within the biopharmaceutical industry, or experience at a health authority.
- Detailed Knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
- Managed first wave Marketing Application and/or LCM submissions
- Managed complex regulatory deliverables across projects/products
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.
AstraZeneca has taken critical steps to protecting colleagues, loved ones, and patients from COVID-19 and its variants.COVID-19 vaccination is required for all US employees, and weekly PCR COVID-19 testing is required for those who are unvaccinated or have an approved accommodation.
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.