Associate Director, Global Regulatory Affairs CMC Devices and Combination Products
4 days ago
Position Summary Do not wait to apply after reading this description a high application volume is expected for this opportunity. The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexion's drug/device portfolio, in‐vitro diagnostics and clinical decision software. This role leads complex projects and supports responses to regulatory agency inquiries for Alexion's commercial and investigational products, helping to ensure successful registration and life‐cycle management of unique and technologically complex products.
Independently manage assigned CMC programs, including daily execution of plans, strategic activities, and compliance for clinical and commercial products.
Lead the development, preparation, and submission of CMC dossiers, technical documentation, Notified Body submissions, 510(k)s, supplements, and renewals for commercial products, maintaining accountability to global regulatory CMC commitments.
Collaborate effectively to ensure regulatory strategies for precision medicine, digital health, and medical devices accommodate drug regulatory and submission plans, including HA engagements and risk mitigations.
Develop proactive regulatory strategies for global CMC product lifecycle management; independently resolve complex issues and manage regulatory risks within project teams.
Investigate opportunities for regulatory innovation, promote novel approaches, and present CMC strategies and plans to management and core teams.
Partner and work closely with key partners both internal and external, providing guidance and expertise on assigned GRA‐CMC device documents and projects. Propose new or revised policies and recommend standard interpretations of global regulations and industry standards. Maintain awareness of global legislation and assess its impact on the business and product development programs.
A Bachelor's degree in a relevant scientific discipline; At least 6 years of Device Regulatory experience in the biopharmaceutical or related industry, with extensive experience reviewing and authoring CMC components for medical devices, combination products, in‐vitro diagnostics, and clinical decision software.
comfortable building relationships with numerous stakeholders in a cross‐functional environment.
The duties of this role are generally conducted in an office environment. Employees must be able to use a computer, engage in communications via phone, video, and electronic messaging, solve problems through analysis and dialogue, collaborate with others, and maintain general availability during standard business hours.
In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. xmcpwfu If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.
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Boston, MA, United States AstraZeneca Full timePosition Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexion’s drug/device portfolio, in‑vitro diagnostics and clinical decision software. This role leads complex...
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Boston, MA, United States AstraZeneca Full timePosition Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexion’s drug/device portfolio, in‑vitro diagnostics and clinical decision software. This role leads complex...
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Boston, MA, United States AstraZeneca Full timePosition Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) Devices and Combination Products plays a pivotal role in the implementation of global CMC regulatory strategies related to Alexions drug/device portfolio, invitro diagnostics and clinical decision software. This role leads complex projects...
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Boston, MA, United States AstraZeneca GmbH Full timePosition Summary The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRACMC) Devices and Combination Products plays a pivotal role in implementation of global CMC regulatory strategies related to Alexions drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and...
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