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This position is based in our Princeton, NJ office with onsite presence 60% of the time and reports to the Head of Regulatory Affairs. Minimum of 10 years of experience within Regulatory Affairs (Oncology experience preferred.
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CMC regulatory affairs, or a related field within the pharmaceutical or medical device industry. Specific certifications related to drug-device combination products or regulatory affairs (e.g., Regulatory Affairs Certification) could be advantageous.
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Including at least 3 years of relevant Regulatory Affairs experience, or Advanced degree (PharmD, PhD, MD or DVM) with at least 2 years of regulatory or relevant pharmaceutical/biotechnology industry experience required.
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He/she/they manages the writing of response to CMC questions from Health Authorities with support from Quality, Global Regulatory Affairs (GRA), technical experts or CMOs. He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global.
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Preference will be given to students who have applied to and have been accepted into the Counselor Education – Student Affairs or Higher Education Administration program by the College of Graduate Studies application deadline.
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This role requires a strong leader with a deep understanding of commercial patient services, pharmacovigilance, quality assurance, and regulatory compliance. As a Quality and Compliance Team Lead, you will serve as a liaison to key clients, where your leadership and expertise will contribute to the continuous improvement of our drug safety processes, regulatory and contract compliance, and overall patient safety.
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Reports To: Vice President, North American Regulatory Affairs and Quality Assurance. The Quality Affairs Director will be responsible for leading the North American GxP compliance efforts across non-production (non-Good Manufacturing Practice/Good Distribution Practice) related areas, including clinical trials, regulatory submissions, and clinical operations.
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This role will develop and lead all medical affairs activities ensuring partnership within the team (medical strategy, scientific communications and publications) all key Medical Affairs functions (Medical Excellence, HEOR, Field Medical, Medical Information) as well as maintaining a high-level cross-functional collaboration across the organization to ensure alignment and One Insmed approach.
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Provide support and leadership to Product Development/R&D, Quality, Regulatory, Operations, Sales & Marketing on all product lifecycle issues, including new product introduction, design changes and product end-of-life issues.
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With a focus on providing talent for patient support, field/inside sales, medical device support, clinical support, and medical affairs our CSMS division has 10,000+ field professionals in more than 30 countries addressing physician and patient needs.
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Supply Chain, Regulatory, or Pharmaceutical manufacturing experience working with third party suppliers. Experience in Supply Chain, Operations, Material Management, Quality, and/or Regulatory, with increasing levels of responsibility in a pharmaceutical or other regulated environment preferred.
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If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email astoncarteraccommodation@astoncarter.com for other accommodation options.
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He/she/they defines and manages the compilation of the documentation, required for the authoring by reaching out to appropriate internal/external functions such as quality, manufacturing, Global Regulatory Affairs (GRA), technical experts from global Client locations or contract manufacturing organizations (CMOs), or alliance partners.
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8+ years of experience in a GMP environment in pharmaceutical, biologics, vaccines, cell or gene therapy operations, including solid experience in Quality Systems and Regulatory CMC. Comprehensive knowledge of global GMP and regulatory requirements for biotechnology, cell and gene therapy products and Quality by Design approaches.
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As part of the Consulting leadership team, the Managing Director - Medical Affairs will contribute to setting business direction, strategy, and priorities and take ownership for driving the overall growth and scalability of the Medical Affairs consulting business.
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regulatory affairs due diligence jobs in Bridgewater, Beech-grove, Indiana
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