CMC Regulatory Submissions Manager - BPD
Do you have a passion for Science? Would you like to apply your expertise to impact a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!
At AstraZeneca, we put patients first and strive to meet their unmet needs worldwide. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. If you are swift to action, confident to lead, willing to collaborate, and curious about what science can do, then you’re our kind of person.
About AstraZeneca in Gaithersburg, MD:
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.
Summary of the group:
Scientific Writing (SW) is part of the Scientific Writing and CMC Project Management group in the Biopharmaceutical Development organization at AstraZeneca. The SW group manages the preparation and review process of regulatory documents for the quality (CMC) modules for global submissions across early and late stage of biologics development, including life-cycle management. Our goal is to provide well written, scientifically sound, and regulatory-compliant documents for biologics in the AstraZeneca pipeline, thereby helping to deliver promising new medicines to the market.
Main Duties & Responsibilities:
Independently with limited guidance performs the following tasks:
- Lead and manage the preparation of CMC sections for clinical trial applications (CTAs), investigator brochures, clinical study protocols, CTA amendments, responses to questions from regulatory agencies, briefing books. May lead preparation of BLA/MAA sections with one or more CMC function
- Manage submission preparation activities for multiple projects at different development stages
- Coordinate and manage work streams within and across departments and across the company. May lead template and procedure preparations including stakeholder management
- Actively participate in project CMC teams and provide the interface between the team and the SW group
- Provides guidance to staff on regulatory submissions and development reports
- Manage preparation and editing documents prepared by junior staff and service providers. May have direct supervisory responsibilities over service providers and junior staff
Education & Experience Requirements:
Bachelor's and 5+ years OR Master's and 3+ years of biopharmaceutical industry experience. Experience with electronic submission systems, editing and reviewing large documents is required. Technical writing experience is desirable, while experience preparing CMC regulatory documents and manuscripts is preferred. RAC or PMP certification is desirable.
- CMC background in biologics such as monoclonal antibodies and/or vaccines.
- Must have strong written and oral communication skills.
- Must have strong interpersonal skills.
- Must be able to work on multiple projects.
- Must be proficient in Microsoft Office.
- Experience in working with Style Guides or Authoring Tools and electronic submission systems.
- Experience in authoring, reviewing, or supporting the preparation of CMC regulatory submission documents
- Experience working in a matrix environment.
- Knowledge and understanding of FDA regulatory requirements and ICH guidelines.
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 recognising their potential. Join us on our journey of building a new kind of organisation to reset expectations of what a bio-pharmaceutical company can be. This means we’re opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you ready to bring new ideas and fresh thinking to the table? Brilliant! We have one seat available and we hope it’s yours.
Where can I find out more?
Check out our landing page for more information on our BPD group https://careers.astrazeneca.com/bpd
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AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.