Job Description

Position 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 and supports responses to regulatory agency inquiries for Alexions commercial and investigational products, helping to ensure successful registration and lifecycle management of unique and technologically complex products.

Primary Responsibilities

• 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 GRACMC device documents and projects. Participate in GMP inspections and lead GRACMC interactions.
• 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.
• Mentor junior staff as needed.

Qualifications

• A Bachelors degree in a relevant scientific discipline; MS or Ph.D. preferred.
• At least 6years of Device Regulatory experience in the biopharmaceutical or related industry, with extensive experience reviewing and authoring CMC components for medical devices, combination products, invitro diagnostics, and clinical decision software.
• Strong understanding of new product development processes, the FDA QSR, Canadian MDR, EU MDR, and IVDR. Experience with additional HAs will be considered.
• Strong written and oral communication skills; comfortable building relationships with numerous stakeholders in a crossfunctional 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.

Our mission is to build an inclusive environment where equal employment opportunities are available to all applicants and employees. In furtherance of that mission, we welcome and consider applications from all qualified candidates, regardless of their protected characteristics. If you have a disability or special need that requires accommodation, please complete the corresponding section in the application form.

Job Tags

Similar Jobs