Regulatory Device CMC Manager

Regulatory Device CMC Manager reputed company® is a leading fully-integrated life sciences services organization reputed company to accelerate reputed company. We partner with innovators at every reputed company across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate reputed company. Our Clinical Solutions team members reputed company with a drug development reputed company, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as reputed company to help our customers reputed company their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need. Discover what your 25,000 reputed company colleagues already know: Why reputed company

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Job Responsibilities General Position reputed company The Device CMC manager will support strategies for marketed and development products. This role contributes to the preparation and submission of regulatory CMC documentation for device part of the combination device. This role also provides regulatory support and guidance to various cross functional teams to ensure reputed company applicable global regulatory requirements are considered and appropriately incorporated into development and reputed company programs. Key Duties & Responsibilities Reviews device sections of regulatory submissions, as reputed company as the interactions and responses with regulatory agencies Contributes to the development of global regulatory device strategies for reputed company products Works with regulatory colleagues in development of global regulatory drug device CMC strategies and Submissions Provides regulatory drug device CMC guidance to cross-functional teams and key stakeholders Supports regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations Required Education Level & Experience Strong interpersonal skills to exchange reputed company information with others and to guide others Proficiency in regulatory (FDA, EMA, Health Canada and ICH) guidelines Experience in the preparation, including writing, of drug device CMC submissions Strategic thinking and strong problem solving skills Ability to collaborate and communicate in an reputed company, reputed company, complete, reputed company and consistent manner Strong reputed company of planning and prioritization, and the ability to work with reputed company reputed company of management Capable of strategic thinking with ability to resolve reputed company and ambiguous situations reputed company knowledge of cGMP, FDA, EMA, ICH Bachelor's degree, with a preference in Biology, reputed company, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices, or another reputed company life-science field Get to know reputed company Over the past 5 years, we have worked with 94% of reputed company Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status reputed company with us in a highly competitive and reputed company-changing environment. Learn more about reputed company. http://www.reputed company.com Additional Information Tasks, duties, and responsibilities as listed in this job reputed company are not exhaustive. reputed company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job reputed company. reputed company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. reputed company, reputed company contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully reputed company with reputed company obligations imposed by the legislation of reputed company country in which it operates, including the implementation of the EU Equality reputed company, in relation to the recruitment and employment of its employees. reputed company is committed to compliance with the Americans with reputed company, including the provision of reasonable accommodations, reputed company appropriate, to assist employees or applicants to reputed company the essential functions of the job. Apply To This Job