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The Team Lead for Authoring Support Group will be part of the Global Regulatory Operations group and will develop and manage the authoring support group within Regulatory Affairs (RA) to ensure timely and high-quality document delivery to the Regulatory Publishing Group.
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Senior Director, Regulatory Affairs Strategy page is loaded Senior Director, Regulatory Affairs Strategy Apply locations Princeton, NJ time type Full time posted on Posted 2 Days Ago job requisition id R10397 At Genmab, we’re committed to building extra(not)ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases.
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Safe and timely execution of Phase I studies; close collaboration with internal and external clinical study support staff and scientists (including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations.
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Kelly® Science & Clinical is seeking a Regulatory Affairs Associate for 1 year contract position (with possibility of extension) position at a premier client in Skillman, NJ. If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.
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Reporting to the Head of US and Above Market Compliance and Ethics Organization, this role partners with senior leaders across Legal, Commercial, Medical, R&D, Global Drug Development, Regulatory, IT, Audit, Finance and HR to build and integrate one global compliance program into the US and Worldwide Commercialization Organizations.
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The Associate Director, Regulatory Operations role is accountable for managing regulatory submission related activities, providing business ownership and management of IT systems within the scope of Regulatory Affairs/Operations.
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Stays up to date and compliant with the regulatory landscape related to drug safety and data analyses. Minimum of - years of experience in data analysis, statistical modeling, and data visualization, preferably within the biopharma or healthcare industry.
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Role: Regulatory Affairs Specialist Medical Device. Min. 3 years in Medical Device Regulatory Affairs. Experience with IVD Devices in Regulatory Affairs. Update procedures to align with regulatory changes, including EU MDR.
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Relationships Reports to: Senior Medical Director Work with the Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Qualifications MD or the international equivalent is required 1+ years Pharmaceutical/Biotech industry experience, including time managing clinical trials, or academic clinical research background Working knowledge of the drug development process required.
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The Regulatory Affairs (RA) Associate Director, Labeling will be responsible for labeling activities across programs and stages of development, with specific responsibility for the United States and the Americas and supporting global needs as required.
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Our East Coast Global Development Hub merges biotech speed and agility with large pharmaceutical company quality, resources, and stability, uniting the best of both worlds to develop new medicines for patients.
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Foster and facilitate communication with Global Regulatory Affairs on these topics, including mentoring of junior staff. Member of the Global Project Team to represent Regulatory Affairs for assigned projects/products.
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Senior Regulatory Affairs Specialist. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) Ensure external communications for regulatory purposes meet regulations.
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Qualifications:Juris Doctorate, with minimum of 3-10 years of legal experience in a law firm, in-house, and/or government role with experience in life sciences and/or healthcare regulatory and compliance issues.
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QUALIFICATIONS Minimum of 6 years in the pharmaceutical industry and a Bachelor’s Degree in a life science -Or- 5 years in the pharmaceutical industry and a Master of Science (M.S.) in Regulatory Affairs or an equivalent advanced degree preferred.
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regulatory affairs jobs in Princeton, NJ
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