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Eu Regulatory Affairs Director/senior Regulatory
hace 3 meses
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.
Who we are
Driven by a sense of purpose, we bring a people-centric approach to everything we do. We support, enable and inspire each other to make exceptional breakthroughs. We encourage different experiences and practices because sharing knowledge and skills provides exciting growth opportunities.
Our transformational leaders set the direction, uniting our organisation behind a common goal - to protect millions of people around the world.
We are empowered to think differently and carve out the path for others to follow, looking forward and working collaboratively.
A place where we lead from the front, inspiring and bringing others on our journey and pushing new ideas with an urgent desire to make a bigger impact.
Our diversity - in culture, language, geography, skills and experience - powers us to serve the global populations we seek to develop medicines for.
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 skilldevelopment, mentoring and performance feedback of other regulatory staff working on the product/project
Your Education, Qualifications, Skills, and Experience
Essential
- Bachelor's Degree in a life science or related field
- More than 5 years experience in early and latestage 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
Desirable
- 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 businesscritical and highprofile development program
- Critical thinking on current regulatory science questions and a good understanding of the corresponding scientific and clinical components
Locations:
UK:
Cambridge; Macclesfield
Spain: Barcelona
Sweden: Gothenburg; Södertälje
Canada: Mississauga
Rewards:
Competitive salary and excellent benefits
Next Steps:
Why AstraZeneca?
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.
