Associate Director, Global Regulatory Affairs CMC Devices and Combination P at AstraZeneca

Boston, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

20 Feb, 26

Salary

0.0

Posted On

22 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, CMC, Devices, Combination Products, Clinical Decision Software, Technical Documentation, GMP Inspections, Risk Management, Communication Skills, Collaboration, Problem Solving, Mentoring, Policy Development, Product Lifecycle Management, Regulatory Innovation, Stakeholder Engagement

Industry

Pharmaceutical Manufacturing

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 implementation of global CMC regulatory strategies related to Alexion’s drug/device portfolio, in vitro diagnostics and clinical decision software leading to successful registration and life-cycle management of unique and technologically complex products. This role will influence complex projects and support responses to regulatory agency inquiries for Alexin’s commercial and investigational products. Primary Responsibilities: • Responsible for independently managing assigned CMC programs, including daily execution of plans, strategic activities, and compliance for clinical and commercial products. • Lead the development, preparation and submission of the CMC dossiers, technical documentation, Notified Body submissions, 510(k)s, supplements, and renewals for commercial products, including accountability to global regulatory CMC commitments. • Establish effective collaborations 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, with limited oversight. Independently resolve complex issues and manage regulatory risks and ambiguous situations within project teams. Investigates opportunities for regulatory innovation / promote the use of novel approaches and present CMC strategies and plans to management and appropriate core teams. • Partner and work closely with key partners both internal and external to the company, providing guidance and expertise on assigned GRA-CMC device documents/projects. Participate in GMP inspections and lead GRA-CMC interactions. • Propose new/revised policies and recommend standard interpretation of global regulations and industry standards. Maintain an awareness of global legislation and assess its impact on the business and product development programs. • Mentor junior staff as needed. Qualifications • A Bachelor’s degree in relevant scientific discipline MS or Ph.D. preferred. • Relevant technical experience in biopharmaceutical or related industry experience with at least 6 years of Device Regulatory experience; extensive experience should be in reviewing, authoring CMC components of medical devices, combination products, in vitro diagnostics and clinical decision software. • Significant understanding of new product development process, the FDA QSR, Canadian MDR, EU MDR and IVDR. Other relevant experience with other HAs will be considered. • Strong written and oral communication skills; comfortable communicating with and building relationships with numerous stakeholders in a cross functional environment. The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and nonlinear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours Date Posted 21-Nov-2025 Closing Date 04-Dec-2025 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. For over three decades, patients and their caregivers have been at the center of everything we do. Every day, we are inspired to follow the science and think differently to create better outcomes for them and their families. Our mission is driven by understanding who they are as unique individuals, not solely defined by their diseases. We’re a leading rare disease company with a diversified projects. Our pioneering legacy in rare diseases is rooted in being the first to translate the complex biology of the complement system into transformative medicines over the past three decades. Today, we continue to push the boundaries of science and deepen our understanding of rare diseases with patient-centricity at the core. This knowledge allows us to innovate and evolve into new areas where needs are unmet and provide an opportunity to help people fully live their best lives.

Responsibilities

The Associate Director will manage assigned CMC programs and lead the development and submission of CMC dossiers and technical documentation for commercial products. This role also involves establishing collaborations for regulatory strategies and mentoring junior staff as needed.