Associate Regulatory Affairs Director

The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strongproject management capabilities responsible for leading the end-to-end planning, coordination, andexecution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy,identifyingsubmission risks and opportunities, while leading regulatory applications and managingprocedures through approval. The ARAD provides regulatoryexpertiseand guidance on procedural anddocumentation requirements to all collaborators and cross-functional teams, working flexibly within andacross regions to ensure the delivery of businessobjectivesglobally.

Accountabilities

• Lead and/or contribute to the planning, preparation, and delivery of both simple andcomplex submissions throughout the product’s life cycle.

• Drive and lead delivery-focused teams, e.g., GRET (Global Regulatory Execution Team)on a product level or RSDT (Regulatory Submission Delivery Team) for major submissions(MAA/NDA).

• Assume overall accountability for the planning, forecasting, and reporting, applying refinedproject and stakeholder management skills, ensuring optimized delivery ofregulatoryactivities to time and quality.

• Provide regulatoryexpertiseon procedural and documentation requirements as defined byHealth Authorities for assigned deliverable(s)including:Submission delivery strategy of all dossiers and all application types permarket and/or region.

• Review documents and provide regulatory input (e.g., response

• documents, high-level documents, study protocols, PSRs, etc.).

• Analysis of regulatory procedures and special designations used duringdevelopment, authorizations, and extension of the product.

• Identifyregulatory risks, opportunities, and proactively develop mitigation strategies foroperational regulatory activities, e.g., planned submissions (with input from all teammembers).

• May assume assigned responsibilities for routine and non-routine contact with healthauthorities and marketing companies.

• As a member of the Regulatory Affairs Manager community, the ARAD willbe a recognized expert in the current regulatory environment.Understand the regulatory framework, including regional trends forvarious typesofapplications, procedures,and documents, in both small and large molecules with aparticular focus on planning, delivery, and project management. Provide coaching, mentoring, and knowledge sharing within the RAM skill group. Contribute to process improvement.

Minimum Requirements:

• Bachelor’s degree in science or a related field with 5+ years of regulatory experience withinthe biopharmaceutical industry or health authority

• Thorough knowledge of drug development

• Strong project management skills

• Leadership skills, including experience leading multi-disciplinary project teams

• Excellent written and verbal communication skills

• Cultural awareness

• Scientific knowledge sufficient to understand regulatory issues andfacilitatescientificdiscussions

•  Ability to work independently and as part of a team

• Influencing and stakeholder management skills

• Ability to analyze problems and recommend actions

• Continuous improvement and knowledge sharing focused

• Desirable Skills/Experience

• Proficiencywith common project management (e.g., MS Project) document managementtools and Veeva Vault/ERV

• Managed complex regulatory deliverables across projects/products

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!

The annual base pay (or hourly rate of compensation) for this position ranges from 135,624.80 - 203,437.20 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.  In addition, our positions offer a short-term incentive bonus opportunity; eligibility to participate in our equity-based long-term incentive program (salaried roles), to receive a retirement contribution (hourly roles), and commission payment eligibility (sales roles). Benefits offered included a qualified retirement program [401(k) plan]; paid vacation and holidays; paid leaves; and, health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans. Additional details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base pay (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.