CMC Regulatory Affairs Manager
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.
Our Gaithersburg, Maryland facility creates life-changing medicines for people around the world. This campus employs more than 3,500 specialists 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 ground breaking technology and lab spaces, all crafted to encourage 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 efficiency 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 myriad of working styles while growing collaboration between teams.
In this role as CMC Regulatory Affairs Manager, you will be responsible for strategy and tactical elements of regulatory submissions for approved biologic products and support our biologics manufacturing sites as needed. This role will actively partner with regulatory therapeutic area counterparts to establish alignment with product regulatory strategies and to communicate CMC-RA CB requirements to team members both internally and externally. This position will also be responsible for the development, compilation, and communication of CMC related documents for the life cycle management of biotech and biologic products.
- Support regulatory representatives on assigned project teams.
- Interacts with other project team members to ensure the timely preparation and receipt of information required for regulatory submissions.
- Monitors related corporate activities for regulatory compliance regarding manufacturing and development.
- Works with senior CMC-RA management, therapeutic regulatory leads and product team colleagues to develop and research and support implementation of CMC regulatory strategy.
- Coordinate CMC regulatory submissions for assigned products. Lead or support development of all major CTD submission elements relating to CMC and effectively communicate comments/recommendations and proactively engage teams to establish solutions to issues.
- Support interactions with Regulatory Agencies on CMC issues.
- Plans, coordinates, prepares, and supports meetings with regulatory agencies.
- Interprets existing regulations and guidance documents within regulatory department and on project teams.
- Participate and/or lead various multi-disciplinary teams or taskforces related to CMC/product development.
- Interact effectively with external business partners.
- BS/MS in a scientific discipline.
- 5+ years of proven experience of increasing documented success in a biopharmaceutical field.
- Strong understanding of regulations governing manufacture of biotechnology products (e.g. monoclonal antibodies).
- Ability to apply critical thinking skills.
- Proven track record in a biotechnology field
- Excellent oral and written communication skills
- Ability to interpret, understand and effectively communicate all relevant FDA, ICH, and global Regulatory Affairs CMC requirements
- Experience working with approved biologics, especially vaccines, is preferred.
- Experience with documentation management systems; firstdoc, Veeva, etc.
- Technical experience in the testing or manufacture of biotechnology-derived products or complex biologics.
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 cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey.
So, what’s next!
Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you.
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them
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.
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Job posted: 2021-08-24