EU Regulatory Affairs Director/Senior Regulatory Affairs Director
Location: Cambridgeshire, Cheshire East
Job Type: Full time
Are you a strategically focused Regulatory Affairs professional and would like to play a central role in crafting innovative drug development strategies and gaining fast, efficient regulatory approvals? If so, read on...
At AstraZeneca, we work with a diverse set of minds, all united by a shared passion to learn, grow and discover.
The Vaccines and Immune Therapies (V&I) group at AstraZeneca is constantly pushing the boundaries of science to deliver medicines to patients. We are applying our expertise in virology, microbiology, and vaccines to enable novel approaches to prevent and treat infectious disease. Within V&I Regulatory Science and Strategy, we take innovative regulatory approaches and work across our pipeline and the business to get medicines to patients as efficiently and effectively as possible. We play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
The EU Regulatory Affairs Director (RAD) is responsible for providing strategic regulatory leadership in the development, commercialization, and management of assigned product(s). The RAD applies knowledge of current local and global regulatory trends to identify future regulatory requirements and strategies, and influences developing views/guidance within leading Health Authorities on specific topics of relevance to their project or regulatory in general.
What you’ll do…
- Develop and implement the EUCAN regional strategy to deliver rapid approval with optimal labelling identified by the business, markets, and patients
- Own the development of the EUCAN regulatory strategy for assigned product(s), and the planning and construction of the global dossier and core prescribing information
- Lead cross functional teams in major EUCAN regulatory submissions, health authority interactions, label discussions, and securing approvals
- Deliver regulatory achievements for assigned project(s), including the assessment of risks and mitigations, emerging data, and the probability of regulatory success
- Ensure effective teamwork across Regulatory Affairs, enabling rapid and effective submissions, approvals, and other product maintenance activities
- Participate in skill-development, mentoring and performance feedback of other regulatory staff working on the product/project
Your Education, Qualifications, Skills, and Experience
- Bachelor’s Degree in a life science or related field
- More than 5 years experience in early and late-stage regulatory drug development, manufacture, commercialization or equivalent
- Previous experience in attending and/or helping a team prepare for a Major Health Authority interactions
- Detailed knowledge of regulatory drug development including product approval/launch. Expert knowledge of regulatory affairs within one or more therapeutic areas
- Ability to think strategically and critically evaluate risks to regulatory activities.
- Proven successful leadership and project management experience
- Previous experience in vaccines or immune therapies is strongly preferred
- Advanced degree in science related field and/or other appropriate knowledge/experience
- Ability to work strategically within a business-critical and high-profile development program
- Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components
UK: Cambridge; Macclesfield Spain: Barcelona Sweden: Gothenburg; Södertälje
Competitive salary and excellent benefits
Are you already envisioning yourself joining our team? Good, because we can’t wait to hear from you. Please apply via the link and one of our team will be in touch ASAP.
*** We will be reviewing applications and shortlisting on a rolling basis - as such there are no closing dates for this position, but early application is advised**
Working here is about more than the science of saving lives. It is about the people who work here. Continuous learning is good for the individual and good for the business too. Being a ‘Great Place to Work’ is central to our culture. If you can contribute in a fast-paced, lean, and entrepreneurial environment, then you’ll feel at home here.
Your curiosity and passion for personal development combined with support from colleagues, mentors, and leaders, will ensure you improve your skills, abilities, and contribution.
You will be offered a competitive salary and excellent benefits, such as Car Allowance, Private Medical Benefits, and much, much more
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 authorization and employment eligibility verification requirements.