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Associate Regulatory Affairs Director
Associate Regulatory Affairs Director – Vaccines & Immune Therapies
Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of working cross functional and global?
At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative Vaccines & Immune Therapies.
We are now looking for passionate colleagues to join our Regulatory Affairs Management team as an Associate Regulatory Affairs Director (ARAD). With us, you will have the opportunity to work across the spectrum of drug development to progress a rich and diverse pipeline.
The role is based at AstraZeneca’s dynamic R&D site in Gaithersburg, MD.
Are you passionate about science and experienced within drug development and regulatory affairs? Would you like to combine your project management skills with your experience of cross functional and global working?
At AstraZeneca, we are driven by innovation and our dedication to make a real-life difference in patients’ lives. That difference starts with you. We need people who share our passion for science and determination to meet patients’ needs around the world. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. Does this match your skills and ambitions for the future? Then join us to be part of the development of innovative Vaccines and Immune Therapies
What you’ll do
The Associate Regulatory Affairs Director (ARAD) is an experienced global regulatory specialist with strong project management capabilities responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables. The ARAD manages delivery of submissions to time, quality, and in compliance with applicable regulations. The ARAD is a key contributor to regulatory submission strategy, identifying submission risks and opportunities, while leading regulatory submissions and managing procedures through approval. The ARAD provides regulatory expertise and guidance on procedural and documentation requirements to Regulatory and cross-functional teams working globally to ensure the delivery of business objectives.
- Understand the regulatory framework, including regional trends, for various types of applications and procedures spanning a product’s lifecycle for Vaccines & Immune Therapies globally.
- Provide regulatory expertise on procedural and documentation requirements as defined by Health Authorities for assigned deliverable(s) including:
- Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of both simple and complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
- Contribute to Submission delivery strategy.
- Review documents and provide regulatory input (e.g., response documents, high level documents, study protocols, Periodic Safety Reports (PSRs), etc.)
- Analysis and implementation of regulatory procedures and special designations used during development, authorizations and extension of the product.
- Develop, execute and maintain submission delivery plans, submission content plans, support operational and compliance activities for assigned deliverables and proactively provide status updates to designated stakeholders.
- Identify regulatory risks and communicate mitigations to Regulatory lead and cross functional teams.
- May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies.
- Provide coaching, mentoring and knowledge sharing within the Regulatory Affairs Management (RAM) skill group.
- Contribute to process improvement to maintain and continuously improve regulatory consistency.
- Oversee general Regulatory compliance in assigned markets/regions and escalate any compliance issues.
Essentials for the Role
- Relevant University Degree in Science or related discipline preferred
- Extensive regulatory experience 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
- Managed first wave Marketing Application and/or LCM submissions
- Managed complex regulatory deliverables across projects/products
Desirable for the Role
- 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 management tools
- Ability to work independently and as part of a team
- Influencing and stakeholder management skills
- Ability to analyze problems and recommend Continuous Improvement and knowledge sharing focused
At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial – finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering groundbreaking methods and bringing unexpected teams together. Interested? Come and join our journey
Desired Skills and Experience
Job posted: 2022-04-24