Director regulatory affairs jobs in the Biotech, R&D, Science category

Primary Duties: Under the direction of the Sr. Director of Regulatory Affairs direct and manage Regulatory Affairs activities for developing and executing CMC strategies across product life cycles. Mange submissions and interactions with the FDA and other regulatory agencies for CMC issues. Provide regulatory support, guidance and expertise to internal groups such as product development, jQA, QC a...
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Director / Senior Manager Regulatory Affairs Post Marketing Basic Responsibilities: · Represent Regulatory Affairs on Promotional Review Committee · Act as the primary point of contact with OPDP · Handle BLA/NDA post approval FDA responsibilities · Oversee Clinical from a Quality perspective Job Requirements: Knowledge and Skills Required: · Minimum 5 years of regulatory affairs post marketing exp...
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TO BE CONSIDERED FOR THIS OPPORTUNITY PLEASE APPLY VIA OUR WEBSITE: https://home.eease.com/recruit2/?id=2739531&t=1 The Director, Regulatory Affairs-CMC is responsible for CMC-related regulatory activities. This person develops and implements regulatory strategies related to CMC throughout drug development from Phase 1 through Phase 4. The Director is also responsible for assessing the regulatory ...
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This position is responsible for the management, development, implementation and coordination of regulatory affairs with a focus on understanding, implementing and insuring compliance with global quality/regulatory requirements. Directs regulatory activities, providing strategic direction, and definition. Manages to ensure all regulatory activities for development and marketed products are achieve...
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Director, Quality Assurance Systems: Growing and Cutting-edge Biotech, NY/NJ area Summary: Our client is a highly attractive and innovative globally traded Biotech Company working on truly cutting-edge therapeutics that would be first-in-class treatments. They are currently seeking a seasoned QA professional to come in and lead their QA Systems function. This ground-floor opportunity offers a best...
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Director, Global Clinical Data Systems: Global Top 25 Pharma - New Jersey Summary: Attractive and challenging Global Director of Clinical Data Systems opportunity with a multi-billion dollar Global Pharma in their New Jersey offices. This is a high visibility position where you will be responsible for overall global oversight of Clinical Systems with a focus in data management and systems operatio...
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Medical Director, Oncology SUMMARY:. Posted (5/1): The Medical Director - Oncology will report to the Chief Medical Officer and will provide medical direction for the Oncology clinical programs. · Lead the clinical strategic efforts for the oncology programs · Lead and develop all protocols for the oncology programs and work closely with the clinical investigators and the project teams · Provide m...
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The job holder will play a key role to shape the brand, image and reputation of Merial as a leading Animal Health Company and a Sanofi Growth Platform. 1. Image and Reputation He/she develops and executes strategies that define, promote and establish Merials image and reputation in line with Sanofi approach He/she works cross-functionally to position corporate messages, create advocacy among exter...
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This position is responsible for assisting in the management of clinical drug supplies for human clinical trials therapeutics clinical products. This position will assist in the management of clinical labeling, packaging and distribution activities conducted at Contract Manufacturing Organizations (CMO). Reporting to the Associate Director of Drug Supply and Distribution, this position will have c...
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The Clinical Project Manager is responsible for independently managing multiple clinical trials of moderate complexity or managing a broader range of activities on large multi-center studies. The Clinical Project Manager is expected to address site and vendor related issues, with assistance as needed. Specific responsibilities include the clinical trial management of timelines, budgets, resources,...
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Our client is a worldwide leader in medical diagnostic instrumentation. They design, manufacture, service and support products specifically designed to advance standards of care worldwide. Their employees contribute directly to the quality of life. They pride themselves in fostering creative thinking and innovative ideas in a team-building environment. They reward success and cultivate open commun...
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