Regulatory Affairs Manager
3 weeks ago
US Tech Solutions is a global staff augmentation firm providing a wide-range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit our website We are constantly on the lookout for professionals to fulfill the staffing needs of our clients, sets the correct expectation and thus becomes an accelerator in the mutual growth of the individual and the organization as well. Keeping the same intent in mind, we would like you to consider the job opening with US Tech Solutions that fits your expertise and skillset. Job Description Serve as the senior and principal regulatory affairs member of project development teams, primarily focused on (but not limited to) drug products. Provide regulatory oversight and guidance to project teams on compliance matters, FDA requirements, clinical study design issues and on timing, logistics and operational recommendations for product development. Develop regulatory submission strategies in agreement with defined product development objectives. Serve as the principal regulatory affairs liaison to FDA and other health authorities for assigned Investigational New Drug (IND) and New Drug Applications (NDA) projects. Prepare and submit IND and NDA applications, as well as various amendments and supplements. Minimum of 5 years + experience in drug development and registration activities , including personal management of an approved new drug from initial development through to approval and market launch. Prior management experience, with a demonstrated capability to lead and motivate staff is essential. Demonstrated strategic development capabilities related to new drug development and commercial support activities are critical. Qualifications Minimum of 5 years + experience in drug development and registration activities , including personal management of an approved new drug from initial development through to approval and market launch. Prepare and submit IND and NDA applications, as well as various amendments and supplements. #J-18808-Ljbffr
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Regulatory Affairs Associate II
3 weeks ago
Lake Forest, United States Manpower Full timeOur client, a leading organization in the medical device industry, is seeking a Regulatory Affairs Associate II to join their team. As a Regulatory Affairs Associate II, you will be part of the Global Regulatory Affairs department supporting regulatory submissions and compliance efforts. The ideal candidate will have strong attention to detail, proactive...
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Lake Forest, United States Alcon Full timeJob Title: Global Regulatory Affairs Principal SpecialistLocation: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CASummary of Position:Alcon is looking to hire a Global Regulatory Affairs Principal Specialist to join our Regulatory Affairs team in Fort Worth, TX, Johns Creek, GA or Lake Forest, CA location. You will be responsible for developing global...
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Lake Forest, United States Alcon Full timeManager II, Regulatory Affairs Strategy for Digital Health At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go...
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Lake Forest, United States Alcon Full timeManager II, Regulatory Affairs Strategy For Digital HealthAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above...
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Manager, Regulatory Affairs
2 days ago
Salt Lake City, United States BD Nogales Norte Full timeCompany Overview BD is one of the largest global medical technology companies in the world. Advancing the world of health™ 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 manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and...
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Global Regulatory Affairs Principal Specialist
2 weeks ago
Lake Forest, CA, United States Alcon Full timeJob Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position: Alcon is looking to hire a Global Regulatory Affairs Principal Specialist to join our Regulatory Affairs team in Fort Worth, TX, Johns Creek, GA or Lake Forest, CA location. You will be responsible for developing global...
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Global Regulatory Affairs Principal Specialist
2 weeks ago
Lake Forest, CA, United States Alcon Full timeJob Title: Global Regulatory Affairs Principal Specialist Location: Fort Worth, TX, Johns Creek, GA, or Lake Forest, CA Summary of Position: Alcon is looking to hire a Global Regulatory Affairs Principal Specialist to join our Regulatory Affairs team in Fort Worth, TX, Johns Creek, GA or Lake Forest, CA location. You will be responsible for developing global...
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Regulatory Affairs Associate II
1 day ago
Lake Forest, Illinois, United States Net2Source (N2S) Full timeNet2Source is a Global Workforce Solutions Company headquartered at NJ, USA with its branch offices in Asia Pacific Region. We are one of the fastest growing IT Consulting company across the USA and we are hiring "Job Title " for one of our clients. We offer a wide gamut of consulting solutions customized to our 450+ clients ranging from Fortune 500/1000 to...
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Associate Director, Regulatory Affairs CMC
4 weeks ago
Lake Forest, United States Allergan Full timeCompany Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...
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Lake Forest, California, United States Alcon Full time $97,500 - $162,500Manager II, Regulatory Affairs Strategy for Digital HealthAt Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above...
