1 Year Contract – Please note that only applications complete with CV will be considered
AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. AstraZeneca is one of the world’s leading pharmaceutical companies. At AstraZeneca, we promote a culture that inspires innovation and collaboration.
The Regulatory Affairs Manager ensures efficient and timely regulatory processes with successful launches and lifecycle management. He/She will contribute to improvement by providing regulatory expertise as well as support across organization with maintaining focus on patients access and safety of medicines.
The assignment is to coordinate and execute all regulatory tasks in the delivery of submissions. This means that:
- You are responsible for management and coordination of the regulatory submissions sent to health authorities.
- You provide operational regulatory input and guidance in cross-functional teams.
- You work flexibly within and across Therapeutic Areas to contribute in business decisions, including brand teams, with regulatory insights and understanding for the regulatory framework.
- You understand the EU regulatory procedures and apply this knowledge in your daily work as well as when strategizing long term.
- You work in a structured way assuring all steps in a task are performed timely.
- You understand and comply with the ways of working and strive for improving those.
- You identify opportunities as well as show stoppers in business related or compliance related areas.
- You master the electronic archiving functionality in the Regulatory function, and you make it easy for others to operate by keeping the structure and good order.
- Responsible for regulatory submissions both on new and established products supporting rapid and high quality approval
- Communicates with authorities on pending issues and changes in regulatory requirements; drives and develops key AZ specific regulatory questions and processes
- Coordinates and develops contacts to regulatory authorities
- Continuously updates stakeholders and TA teams on regulatory requirements and timelines for completing / managing regulatory activities
- Ensures AZ practices / texts / other materials meet external requirements and AZ policies (e.g. labelling; compendial and translation CRO)
- Works in close cooperation with European and global regulatory
- Follows up trends and changes in regulation; does competitive intelligence within the field of regulatory responsibility
- Contributes to the development of an effective team
- Ensure personal competence development
- Contributes to the overall development of the department and positive attitude towards working and developing
- Active contribution to continuous improvements within the function
- Assures tasks are of correct quality and in accordance with written procedures and current legal requirements and internal standards
Typical accountabilities and Responsibilities
- You work in a structured way assuring all steps in a task are performed timely. You understand and comply with the ways of working and strive for improving those. You master the electronic archiving functionality in the Regulatory function, and you make it easy for others to operate by keeping the structure and good order.
- You contribute in business decisions, including brand teams, with regulatory insights and understanding for the regulatory framework. You transform regulatory information and status into business insights. You identify opportunities as well as show stoppers in business related or compliance related areas.
- The regulatory legislation is complex, and has a span over a large area from distribution to early research related tasks. You understand the EU regulatory procedures and apply this knowledge in your daily work as well as when strategizing long term.
- You interpret and can also influence legislation, and make conclusions related to business impact leading to business opportunities.
- Master’s degree in Pharmacy, Chemistry, Biology or equivalent
- Demonstrated experience with Regulatory work by working in one or more areas in regulatory affairs in the pharmaceutical or related industry, or experience at a health authority
- Excellent written and verbal communication skills
- Excellent knowledge of English and at least one of the Nordic languages
- Good knowledge of relevant legislation requirements and procedures
- Strong ability to work collaboratively
Education and Experience, essential
- Experience from pharmaceutical development, manufacturing
- Experience from health authority work
- Solid business acumen and a good RA toolbox to apply
- Good at influencing and building relationships with senior stakeholders
- Ability to plan, communicate and drive processes and projects all the way to the finish line
Key relationships to reach solution
- Global Regulatory Affairs teams
- European Regulatory Affairs
- Regulatory CMC teams
- TA teams
- Medical function
- Logistic function
- Labelling and translation CRO
- National Health Authorities
- Local / National trade associations and working groups
Sthree Germany is acting as an Employment Business in relation to this vacancy.