Associate Regulatory Affairs Director
Would you like to apply your Regulatory Affairs expertise and passion to make an impact in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we do this with integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 experts in our field and is only a short drive from Washington, DC. This modern and vibrant scientific campus is the home of R&D and Oncology in the US. Here, we play host to some of the most cutting-edge technology and lab spaces, all designed to inspire collaboration and cross-functional science. We believe employees benefit from being challenged and inspired at work. We are dedicated to creating a culture of inclusion and collaboration.
The Gaithersburg site offers a variety of amenities to help boost productivity and help keep our employees happy and healthy. This includes a fitness center, employee healthcare clinic, electric vehicle charging stations, dry cleaning, full-service cafeteria and copy center. This is where you’ll find newly-designed, activity-based work spaces to suit a variety of working styles while increasing collaboration between teams.
The Associate Regulatory Affairs Director (ARAD) is an experienced regulatory professional with understanding of regional regulatory strategy. The ARAD is responsible for leading the end-to-end planning, coordination, and execution of assigned deliverables and contributes strategic insight into the development, commercialization and life cycle management of assigned products.
The ARAD leads simple through more complex regulatory applications and provides regulatory expertise and guidance on procedural and documentation requirements to the global regulatory strategy team and cross-functional teams, working flexibly within and across regions to ensure the delivery of business objectives. The ARAD contributes to regulatory strategy by identifying risks and opportunities, leading review of regulatory and competitive intelligence, supporting interactions with health authorities, and taking responsibility for license maintenance activities.
Understand the regulatory framework, including regional trends, for various types of applications and procedures for small and large molecules.
Support regulatory intelligence activities activities to inform strategic decision making.
Support preparation of the cross functional team and participate in / lead (as appropriate) key health authority consultations.
May assume assigned responsibilities for routine and non-routine contact with health authorities and marketing companies. Review and approve content of responses to queries form HAs.
Provide strategic regulatory input on key documents including:
Submission delivery strategy of all dossiers and all application types per market and /or region.
Review of documents (e.g. response documents, PSRs, etc.).
Analysis of regulatory procedures and special designations used during development, authorizations and extension of the product.
Use and share best practices, when handling various applications and procedures during interactions with health authorities and in day-to-day work, while operating in a highly dynamic environment.
Lead and / or contribute to the planning, preparation (including authoring where relevant) and delivery of simple and with experience, increasingly more complex submissions throughout the product’s life cycle from either a global and/or regional perspective.
Identify regulatory risks and propose mitigations to regional RADs and GRLs and cross functional teams.
Contribute to process improvement.
Relevant university degree in science or related discipline. Advanced degree is preferred but not required.
Experience within the biopharmaceutical industry, or at a health authority, or other relevant experience, with 1-2 years experience in regulatory strategy
General knowledge of drug development
Leadership skills, including experience leading multi-disciplinary project teams
Strategic regulatory experience in oncology drug development
Thorough knowledge of the drug development process
Skills and Capabilities:
Excellent written and verbal communication skills
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 actions
Continuous Improvement and knowledge sharing focused
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 envisioning yourself joining our team? Good, because we can’t wait to hear from you!
Competitive salary and benefits package on offer
Competitive salary and benefits package on offer. The successful candidate will have access to pension contributions, A performance recognition scheme and a competitive, generous remuneration package.
Where can I find out more?
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Closing Date15-Feb-2024Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.