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About the Role

The Regulatory Affairs Associate (RAA) assists Regulatory Affairs Management (RAM) in obtaining and maintaining licenses and applications, adhering to regulatory strategy and AstraZeneca standards.

Responsibilities

• Document management including uploading and tracking regulatory files and systems.
• Planning, preparing and executing simple submissions, and assisting with the preparation and planning of regulatory dispatches.
• Acting as the interface with Health Authority (HA) and its systems for designated regulatory tasks.
• Ordering and tracking specific regulatory requirements such as Registration samples, Certificates of Pharmaceutical Product, and Legal documentation.
• Providing support across the group for assigned non-drug project roles & responsibilities.
• Providing coaching, mentoring and knowledge sharing within the RAM skill group.
• Contributing to process improvement.

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.

Skills

• 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

Location

• Remote

Work Type

• Full-time

Experience Level

• 1-3 years

Education Level

• Associate's degree
• Bachelor's degree

Salary/Compensations

• $85,248.00 - $127,872.00 USD Annual

Benefits

• Short-term incentive bonus opportunity
• Equity-based long-term incentive program (salaried roles)
• Retirement contribution (hourly roles)
• Commission payment eligibility (sales roles)
• Qualified retirement program [401(k) plan]
• Paid vacation and holidays
• Paid leaves
• Health benefits including medical, prescription drug, dental, and vision coverage

About the Company

• 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.

Equal Opportunity

• Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees.
• In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics.
• If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.