Regulatory Affairs Associate

About the role

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.

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.
• 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).
• 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), and translations of regulatory documentation.
• Provide support across the group for assigned non-drug project roles and 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.

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, at a health authority, or other relevant experience.
• Relevant experience in science from the biopharmaceutical industry or other relevant experience.
• Proficient verbal and written English.
• Project Management skills.
• Experience in document management and tracking databases.

Preferred Qualifications

• 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, 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

• 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

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

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Health benefits including medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility to participate in equity-based long-term incentive program (salaried roles).
• Retirement contribution (hourly roles).

Pay

The annual base pay for this position ranges from $85,248.00 - $127,872.00 USD. Hourly and salaried non-exempt employees will also be paid overtime pay when working qualifying overtime hours. Base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience.