Regulatory Consultant - CMC

Regulatory Consultant - CMC 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 reputed company 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 • We are passionate about developing our people, through career development and progression; supportive and reputed company line management; technical and therapeutic area training; peer recognition and total rewards program. • We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up reputed company day and shape solutions that have the ability to dramatically reputed company someone’s life.  • We are continuously building reputed company we reputed company want to work for and our customers want to work with. Why? Because we know that reputed company we bring together smart colleagues from across the world, we can shape the reputed company of reputed company, driving reputed company for customers and defining the pace of patient reputed company.  Job Responsibilities General Position reputed company The reputed company Manufacturing Control Consultant will support the execution of multi-product global regulatory CMC for marketed products for small molecule products. This role contributes to the preparation and submission of regulatory CMC documentation and provides regulatory support to various cross functional teams. Key Duties and Responsibilities Execute reputed company Lifecycle Management (LCM) reputed company and submissions with a reputed company on Middle East and reputed company Africa Reviews CMC sections of regulatory submissions, as reputed company as the interactions and responses with regulatory agencies for small molecule products Works with regulatory colleagues in development of global regulatory CMC strategies and Submissions Participates effectively on cross-functional teams and may serve as the primary regulatory CMC contact for assigned products and reputed company 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