Regulatory Affairs Manager, Respiratory and Immunology

Do you have knowledge within Regulatory Affairs and want to develop your skills within project management?

At AstraZeneca, we offer you a unique experience to work in cross functional teams with all phases of drug development, from clinical trials to marketing authorization applications worldwide. You will lead the end-to-end planning, coordination and execution of our submissions and contribute to regulatory submission strategy. Does this match your skills and ambitions for the future? Then join us to develop future treatments in the Respiratory and Immunology Therapy Area.

At AstraZeneca, we are more than 65.000 people in over 100 countries. Our aim is simply to positively impact patients’ lives together, as our pipeline of innovative medicines consistently grows. As an industry leading Regulatory function, we’re focused and committed to the development of our products as well as to our people.

About the position
We are now seeking new members to join our Regulatory Affairs Management team within the Respiratory and Immunology Therapy Area, in the role as Regulatory Affairs Manager (RAM).The role will be based at AstraZeneca’s dynamic R&D site in Gothenburg, Sweden. With employees from more than 50 countries, our Gothenburg site is a truly inspiring place to work.

Working in the role as Regulatory Affairs Manager (RAM) you will contribute to regulatory submission strategy, identify submission risks and opportunities, while leading simple through more complex regulatory applications and managing procedures through approval.

Responsibilities
Your main accountabilities/responsibilities:
• Lead and/or contribute to the planning, preparation, and delivery of submissions of varying complexity throughout the product’s life cycle from either a global and/or regional perspective.
• Provide regulatory input/ expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including submission delivery strategy of all dossiers and all application types per market and/or region and review of documents, e.g., response documents, study protocols, periodic safety reports
• Support operational and compliance activities for assigned regulatory tasks
• Provide coaching, mentoring and knowledge sharing within the regulatory skill group
• Contribute to and lead process improvement
• Identify regulatory risks and propose mitigations to appropriate member of cross functional teams

Your profile
To be successful in this role, we believe that you have a
• University degree in science or a related field
• Minimum of 2 years of regulatory experience within the biopharmaceutical industry or similar.
• We believe that you possess good project management skills as well as leaderships skills
• Excellent written and verbal communication skills.
If you have previous experience in leading multi-disciplinary project teams, this will be an advantage.

About the organisation
This position is a consultant assignment at AstraZeneca via QRIOS Life Science & Engineering in Göteborg for one year. During this time you will be employed by QRIOS Life Science & Engineering.
QRIOS employs curious experts in IT, Life Science and Engineering. We want to continue to attract the best employees, to continue to support our partners with the important competences you require. We are a recruitment and consulting company that is strongly inspired by those who never stop looking for new solutions. As we say, QRIOS MINDS GO FURTHER

Why AstraZeneca?

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. Always committed to lifelong learning, growth and development.