Senior Manager, Regulatory Affairs - Durham, NC

The Manager, Regulatory Affairs drives key regulatory activities while supporting PBI's innovative gene editing programs for chronic Hepatitis B virus infection and Duchenne's muscular dystrophy. · Essential Duties and Responsibilities · Drives timely submission and approval of r ...

Job summaryThe Manager Regulatory Affairs drives key regulatory activities working seamlessly across functions to translate scientific clinical and technical insights into high-quality regulatory submissions while supporting regulatory strategy across the organization. · ...

+The Director of Regulatory Affairs at Pharmaceuticals will work closely with product development core teams and sub teams in setting company goals and work closely with these groups in meeting company goals. · +Bachelor's degree required (advanced degree MS, PhD, PharmD, MD pref ...

Perform assessment of CMC changes, identifying global regulatory requirements. · ...

This position will support Regulatory Affairs projects that support the Pharmacy Automation business in BD-Connected Care. · Carry out related regulatory affairs activities such as development, execution and management of submissions. · ...

Job summaryWe are the makers of possible BD is one of the largest global medical technology companies in the world Advancing the world of healthTM is our Purpose and it's no small feat It takes the imagination and passion of all of us from design and engineering to the manufactur ...

This position is responsible for support of a variety of regulatory activities and projects. · Assess and communicate the impact of new and changing regulatory requirements and standards. · ...

+The Senior Manager of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs.This position is responsible for supporting MMS Pharmacy Automation products and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. · + ...

We are the makers of possible BD is one of the largest global medical technology companies in the world. · The Senior Manager of Regulatory Affairs reports directly to the Senior Director of Regulatory Affairs This position is responsible for supporting MMS Pharmacy Automation pr ...

Developing global regulatory submissions for medical device industry with EU MDR experience required. · ...

++This position performs specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for regulatory approval. · +++Prepares robust regulatory applications to achieve departmental and organizational objectives. · Creats reviews and ...

We believe that the human element across our global teams is what allows us to continually evolve Join us and discover an environment in which you ll be supported to learn grow and become your best self Become a maker of possible with us. · Minimum of 8 years of directly related ...

We are seeking a Regulatory Affairs Specialist to support regulatory submissions lifecycle management compliance activities for pharmaceutical medical device products. · This is a W2 contract role supporting ongoing regulatory operations in a fast-paced GxP environment. · Prepare ...

In this critical role you will lead regulatory strategies product submissions and a team of talented regulatory affairs professionals to drive timely product approvals and ensure ongoing regulatory compliance in key markets such as USA EU China and more. · ...

The Regulatory Affairs Specialist is responsible to develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, · Author EU MDR technical files and will contribute to other international regulatory submissions. · Particip ...

The Regulatory Affairs Specialist is responsible to develop and execute the regulatory strategy for new product development, design changes, and field safety corrections, · Author EU MDR technical files and will contribute to other international regulatory submissions. · Particip ...

Atlantic Medical Management (AMM) is seeking an Regulatory Affairs Assistant to perform responsibilities in support of the Compliance department within AMM. · ...

Job summaryThe Regulatory Affairs Specialist is responsible to develop and execute the regulatory strategy for new product development... · ...

We are seeking a Regulatory Affairs Specialist to support regulatory submissions lifecycle management and compliance activities for pharmaceutical or medical device products. · 2–5+ years of Regulatory Affairs experience (Pharma Biotech or Medical Devices) · Strong knowledge of F ...

The Regulatory Affairs Specialist will be responsible for a wide variety of regulatory activities for sustaining products including medical devices and Software as Medical Device (SaMD) and regulatory operation. · ...