The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading complex regulatory applications and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to cross-functional teams working flexibly within and across regions on different phases of drug development to ensure the delivery of business objectives.
Accountabilities/Responsibilities:- Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules across all regions.
- Provide regulatory 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
- Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, Periodic Safety Reports, etc.)
- Use and share guidelines, when handling various applications and procedures, while operating in a highly dynamic environment.
- 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.
- Lead multi-disciplinary project teams.
- Develop, implement and maintain submission delivery plans, submission content plans, and proactively provide status updates to designated collaborators.
- Identify regulatory risks and communicate mitigations to appropriate member of cross functional teams.
- Support operational and compliance activities for assigned regulatory tasks.
- Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management skill group.
- Contribute to process improvement.
Minimum Requirements - Education and Experience- Relevant University Degree in Science or related discipline
- Extensive regulatory experience (5+ years) within the biopharmaceutical industry, or experience at a health authority
- Thorough Knowledge of drug development
- Strong project management skills
- Leadership skills, including experience leading multi-disciplinary project teams
Preferred Experience- Knowledge of the Respiratory & Immunology therapy area.
- Managed first wave Marketing Application and/or Life Cycle Management submissions
- Managed complex regulatory deliverables across projects/products
- Veeva Vault experience
- Knowledge of AZ Business and processes
- Demonstrate high ability to use AI digital tools and solutions
Skills and Capabilities- Excellent written and verbal communication skills
- Cultural awareness
- Scientific knowledge sufficient to understand regulatory issues and facilitate scientific discussions
- Proficiency with common project management (e.g., MS Project) and document managementtools
- 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
Are you interested in working at AZ, apply today!Annual base salary for this position ranges from 133,311.20 to 174,970.95.
AstraZeneca is committed to providing fair and equitable compensation opportunities to all colleagues. Our compensation policies and practices have been designed to allow colleagues to progress through the salary range over time as they progress in their role. The range provided in this posting represents an offer pay range used in a majority of situations. The base pay offered will vary depending on multiple individualized factors, including the candidate's skills and experience, job-related knowledge, and other specific business and organizational needs. In some cases, offers outside the range may also be considered to address unique circumstances.
In addition, our permanent positions offer an annual Variable Pay Bonus/Short Term Incentive opportunity as well as eligibility to participate in our equity-based long-term incentive program (if applicable to role). Benefits offered for permanent roles include a competitive Flex Benefits & Retirement Savings Program, 4 weeks' paid vacation, and annual Personal Days. Fixed Term Contract/Temporary positions (excluding students) are offered a Contract Benefits Program.
We are using AI as part of the recruitment process.
This advertisement relates to a current vacancy.
