Regulatory Affairs Manager
for limited 1 year period, 0,5 FTE position.
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 position holder will be responsible for full scope of Regulatory Affairs tasks in his/her RARE DISEASE therapeutical area, and support business activities with providing professional advice for the different other functions.
MAIN DUTIES AND RESPONSIBILITIES
Managing Regulatory Processes
- EU Regulatory Processes (Centralized Procedures): Keeping contact with global headquarter, license partner and health authorities, providing country specific information to them, furthermore preparing and coordinating of translations of documentations in each phase of the centralized procedures.
- Product Life Cycle Management: Maintenance and compliance of registration data of the registered products (variations, safety updates, renewals).
- Supporting Artwork development processes: Active contribution to the registered products’ artwork projects with development, review and/or approval responsibility.
- Managing the donation process at the local HA level.
- Operational Activities & Data Archiving
- Professional archiving of the registration documentations belonging to his/her therapeutic area in compliance with the company procedures.
- Actively contributing to the regulatory planning.
Business support activities
- Acting as regulatory consultant in related questions belonging to his/her competence.
- Providing product information in his/her therapeutical area to Medical, Sales and Marketing functions.
- Giving advice in promotional affairs.
- Liaisoning with Medical, Market Access, Quality Assurance, Business Unit/Marketing, Supply Chain, Logistics and Finance Departments.
- Strategy and Planning
- Supporting product launch strategies.
- Involvement in local regulatory budget estimates (HA fees, cost of other regulatory activities).
Regulatory Intelligence
- Knowledge of current national and EU regulations ensuring the highest professional level in his/her fields of responsibility.
- Company procedures
- Ensuring compliance to all relevant global or local policies and procedures with a special focus on Regulatory related processes.
ESSENTIAL REQUIREMENTS
- University degree in Pharmacy, Medical, Biology or Natural Sciences
- 4-5 years regulatory experience in pharmaceutical industry
- Experience with Centralized EU Regulatory procedures
- Proficiency in the Quality Review Document preparation
- Fluent English both in written and spoken language.
- Computer literacy (Microsoft Office, Adobe Acrobat, Outlook)
- Driving license “B” and driving practice
PERSONAL PROFILE:
- Analytical skills and able to synthetize
- Open to challenges
- Result orientation
- Precise and reliable
- Excellent communication and problem solving skills
- Able to work independently and also in team
- Open to learn
WHAT WE OFFER?
- Innovative place to work
- Great team
- Competitive salary and bonus
- Company car, laptop, phone,
- Continuous growing possibilities.
- Company car
Why AstraZeneca?
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial - finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
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.
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.
So, what’s next!
- Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
- Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours
Where can I find out more?
- Our Social Media, Follow AstraZeneca on LinkedIn: https://www.linkedin.com/company/1603/
- Inclusion & Diversity: https://careers.astrazeneca.com/inclusion-diversity
- Career Site: https://careers.astrazeneca.com/
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