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24.06.2024
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Teva Manager Regulatory Affairs United States, New Jersey
Requires a Bachelor’s degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage...
Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the...
Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams. Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written...
With management input author and review China, South Korea, Japan and additional international submissions, with guidance for new products and product changes as required to ensure timely approvals/clearance/licensurefor market release....
Provide strategic regulatory expertise and operational direction to management, internal, and external customers to ensure conformance with corporate requirements, government regulations, guidelines and industry standards as it relates to human...
With support from the supervisor, is responsible for maintain the regulatory compliance of marketed products, including annual reporting and safety reporting requirements. Participates in cross functional teams including Global Regulatory...
Bachelor's degree in Engineering, Mathematics, Quantitative Science, or related technical field, or equivalent practical experience. 4 years of experience working in data analytics, consulting, data science, engineering, or a technical...
Requires a Bachelor’s degree in Pharmacy Administration, Pharmaceutical Science, Regulatory Affairs, or a related field, and 3 years of Regulatory Affairs experience. Must have 2 years of sterile/ parenteral dosage...
Are you an experienced regulatory affairs specialist looking for an opportunity to take your career to the next level? Look no further than a Regulatory Affairs Manager position with Expoint. Our exclusive tech job search platform is designed to create connections between employers and qualified experts in a wide variety of technology-related fields.
As a Regulatory Affairs Manager, you will work with technology companies to ensure the success and quality of the products they bring to market. Your primary responsibility will be to ensure the company develops and follows all regulations, standards, and policies set out by government agencies and industry bodies. You will also create and manage quality systems and processes, working with regulatory agencies and other stakeholders to ensure compliance with applicable regulations and standards.
You will be highly knowledgeable in the regulations and guidelines associated with the industry, and you will be a leader in understanding and advocating for the industry with government officials. As a Regulatory Affairs Manager, you will use your highly developed research skills and problem-solving abilities to identify and evaluate potential risks. You will also create regulatory strategies for product development and launches, and assess product compliance with applicable laws and regulations.
To excel in this role, you must have excellent communication skills and the ability to work with a variety of stakeholders across multiple industries. Your excellent organizational and planning skills will be highly valued, and you must be comfortable working independently and as part of a team.
We are looking for a highly-driven and detail-oriented individual who is passionate about technology, has a strong understanding of regulations, and is able to think critically to solve complex problems. If this sounds like you, join our platform today and take the next step in your career!