---

---

Location

Gaithersburg, MD | United States

---

Job description

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.

The Respiratory & Immunology portfolio includes several different scientific areas. The Senior Regulatory Project Director (Sr RAPD) responsibilities will be working across these TA areas (aka TA pillars). The Senior Regulatory Project Director (Sr RAPD) leads and has oversight of all RAM delivery activities for the assigned projects, including license maintenance, and collaborates with the Executive Director Regulatory Affairs Management, lead RPMs/RAPDs and Sr RAGD for the respective TA Pillar to contribute to the global drug project team’s deliverables and associated plans.

In collaboration with the respective Sr RAGD and lead RPMs/RAPDs, develops and shapes the strategic direction of the group, ensuring the appropriate change projects are implemented for improved planning, capacity management, processes and performance. Supports and advises line managers to ensures appropriate resource and project planning and staff assignment to support drug projects.

Your responsibilities include, but are not limited to:

• Be a recognized expert in the current regulatory environment. Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions with a particular focus on planning and capacity management.
• Leads indirectly the group of Regulatory professionals, lead RPMs, RAPDs, responsible for delivery across all regions to contribute to the global drug project team's deliverables and plans.
• Provide regulatory input to peer/project reviews as required
• Support analysis of regulatory procedures ensuring optimal delivery pathways, special designations, authorizations and extensions of the projects are considered during development, for the assigned portfolio.
• Establishes and develops external relationships with key AZ Regulatory cross functional collaborators, demonstrating these for effective team collaboration and delivery of projects with a focus on planning and delivery.
• Leads communication internally and externally of the teams’ achievements and innovative approaches todelivery.
• Within the assigned portfolio, a Sr RAPD may also take on aspects of GRET leadership
• Has an in-depth knowledge and understanding of RAM roles, Submission Excellence and regulatory operating model and can support SDTLs/LRPMs/RAPDs within the assigned portfolio as needed with typicalactivities at a global and/or regional level. This could include but is not limited to development, execution and maintenance of submission delivery plans, submission content plans, stakeholder management, collaborate with MCs, effective processes, planning and capacity management.
• Working collaboratively with the Sr RAGDs, has oversight of and provides direction for continuous improvement and business development projects required within the TA pillars.
• Be a visible, approachable leader and role model for the whole R&I regulatory community within AstraZeneca and within appropriate external professional networks

Minimum Qualifications:

• Bachelor’s in Life Sciences, Pharmacy, or Medicine or another relevant business field
• 10+ years’ experience of working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
• Effective project and resource management; proven ability to handle and lead a broad range of cross-functional customers and team members
• Ability to analyse problems and recommend actions disseminating complex information to a wide audience
• Excellent written and verbal communication skills
• Continuous Improvement and knowledge sharing focused.
• Influencing and stakeholder management skills.
• Cultural awareness

Desirable Qualifications:

• PhD in Life Sciences, Pharmacy, or Medicine or another relevant business field
• Resource Management
• Staff development
• Budget management
• Process improvement

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!

Where can I find out more?

Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

Date Posted

05-Mar-2024

Closing Date

19-Mar-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.

---

Job tags

---

---

Salary