Regulatory Affairs Associate

Regulatory Affairs Associate

The Regulatory Affairs Associate (RAA) assists other members of Regulatory Affairs Management (RAM) in obtaining and maintaining licenses and applications in accordance with agreed regulatory strategy and AstraZeneca standards.

Accountabilities/Responsibilities

• Document management including uploading and tracking regulatory files and systems according to established AZ procedures and regulatory requirements.
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Be the interface with Health Authority (HA) and its systems for designated regulatory tasks e.g. management of user fees, receipt of incoming FDA correspondence, ordering EudraCT number, EudraLink support, use of HA Portals.
• Responsible for the ordering and tracking of specific regulatory requirements such as Registration samples, Certificates of Pharmaceutical Product, Legal documentation e.g. Letters of Authorization, Powers of Attorney, Translations of regulatory documentation.
• Provide support across the group for assigned non-drug project roles & responsibilities e.g. act as a designated point of contact or superuser.
• Provide coaching, mentoring and knowledge sharing within the RAM skill group.
• Contribute to process improvement.

Minimum Requirements

• Associate's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 1 - 3 years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Relevant experience in science from biopharmaceutical industry, or other relevant experience
• Proficient verbal and written English
• Project Management skills
• Experience in document management and tracking databases

Preferred Experience

• Bachelor's degree in a scientific discipline, Regulatory Sciences, Pharmacy, or a related field.
• 3+ years of experience in Regulatory / Drug Development(Industry or Health Authority) 1+ years of Regulatory experience within the biopharmaceutical industry, or at a health authority, or other relevant experience
• Some regulatory/medical/technical experience
• Knowledge of AZ business and processes
• Some knowledge of AZ submission, compilation, publishing and approval processes, standards, systems and tools

Skills and Capabilities

• Good written and verbal communication skills
• Cultural awareness
• Proficiency with common document management tools
• Ability to work independently and as part of a team
• Continuous Improvement and knowledge sharing focused

Internal and External Contacts/Customers

• Lead RPM and members of the GRET and GRST
• Regulatory skill group in CGT
• Marketing Companies
• Health Authorities
• External collaboration partners
• AstraZeneca Legal

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, and always committed to lifelong learning, growth and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

Are you already imagining yourself joining our team? Good, because we can't wait to hear from you!