Executive Regulatory Science Director, Respiratory & Immunology
Opportunity: Executive Regulatory Science Director, Respiratory & Immunology
Locations: Gaithersburg, MD / Durham, NC/ Cambridge, UK / Gothenburg, Sweden
Salary: Competitive, with excellent benefits
Are you a passionate leader with an extensive experience within regulatory affairs and drug development? Do you possess strategic leadership skills and have a broad experience within the Respiratory & Immunology (R&I) area? Then, join us at AstraZeneca R&I regulatory affairs and get involved in the global regulatory strategies and support the research, development and commercialization of our products across the portfolio!
AstraZeneca’s pipeline of innovative medicines is consistently growing within Respiratory & Immunology (R&I). Within R&I Regulatory Affairs we take innovative regulatory approaches to bring these R&I life-changing treatments to those who need it – working across our early and late-stage development pipeline and the business as efficiently and effectively as possible. As an industry leading R&I Regulatory function, we’re focused and committed to the development of our products as well as to our people – providing an open and supportive space to explore, learn and develop across all regulatory roles and levels.
We are more than 65.000 people in over 100 countries. Our aim is simple to positively impact lives together. Using the power of science and innovation, our people improve the impact medicine has on patients. Together, we explore the world of science through our remarkable product pipeline and we take our understanding of the R&I therapeutic area to a whole new level by seeking new treatments.
We are now offering an exciting opportunity for an Executive Regulatory Science Director to join our group within R&I. This role is preferable based at AstraZeneca’s dynamic R&D site in Gaithersburg, MD (US), Durham, NC (US), Cambridge (UK), Gothenburg (SE).
What you’ll do
As the Executive Regulatory Science Director, you are responsible for line managing Regulatory Affairs Directors (RADs). You will report directly to Vice President Regulatory R&I. In this role, you will possess strategic leadership skills and have a deep understanding of global regulatory science, the overall drug development processes and strategies to influence cross functional discussions with relevant senior internal and external stakeholders.
How will you make a difference?
In this role, you will:
- Partner with and mentor the Regulatory Affairs Directors (RADs) aligning on global innovative regulatory strategies for our products and ensure it is consistent with the R&I portfolio strategy
- Provide critical review and input on disease area or portfolio regulatory strategies, risk planning and mitigations
- Ensure disease area global regulatory strategy take into account key regional considerations
- Effectively represent the regulatory function in senior level interactions at internal governance technical review committees, key global health authority meetings and external partners
- Work in collaboration with regional policy and intelligence groups to critically analyze the assessment of emerging regulatory science, data and changes in the regulatory environment and advise senior management on R&I (product) risks/mitigation activities accordingly
- Define and drive disease area regulatory policies and priorities within R&I with internal and external stakeholders
- Lead budget management, resource planning and recruitment of staff. In addition, provide coaching, mentoring, skill development and performance feedback to RADs as well as other (regulatory) staff
- Review and approve high-level documents for global regulatory submissions as well as core prescribing information
- Lead complex non-drug projects (cross-functional or cross-SET area) on behalf of Global Regulatory Affairs (GRA) when necessary
- Ensure submission excellence framework is timely and consistently applied across projects including sharing best submission practices and knowledge and using existing tools
What you’ll need:
- Bachelor’s degree in life sciences and/or science related field and/or other appropriate knowledge/experience (Advanced degree in a scientific discipline is preferred)
- More than 10 years drug development experience
- Experience in global regulatory strategy and submissions that have progressed through to registration
- Significant experience in leading major health Authority interactions
- Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority
- Broad experience of the Respiratory & Immunology therapeutic area, with preferably specific disease area regulatory sciences expertise
- Experience in managing people in a matrixed organizational structure
- Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities
- Effective judgement and decision-making in complex business critical situations
- Excellent collaboration, team working, oral and written communication skills
- Willingness to undertake domestic and international travel
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 us? Good, because we can’t wait to hear from you!
Welcome with your application (CV and cover letter). We will review the applications continuously so please apply as soon as possible.
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.