Labeling Strategist, Global Regulatory Affairs - Vaccine
Posted on: 2 Apr 2021
Swiftwater, PA
Job Description
Position Overview:
The purpose of the position is to prepare Corporate, US and EU labeling (prescribing information, patient information and other labeling components) documents for developmental, Life Cycle Management and marketed products to obtain company and/or agency approval.
Key Responsibilities:
Development or updates of labeling is based on CMC or clinical data from internal or external source such as literature or other information relevant to the product or product class. The position includes the coordination of labeling review and approval throughout the company; preparation of labeling components for submission to regulatory agencies; participation in labeling negotiations with agencies resulting in product approvals or labeling updates; and release of labeling for use throughout the company; review of local labeling and participation with affiliates in agency replies for local issues and to assure compliance with corporate labeling. The position also includes mentoring of junior employees in labeling processes and procedures.
Competencies:
Detailed knowledge of US, EU and other local regulatory requirements pertaining to labeling, marketing authorization filings for new vaccines or updates to existing vaccines;
Knowledge of vaccine development and life cycle
Knowledge of labeling requirements in all regions;
Strong organizational skills and ability to network and coordinate discussions across all levels of the company to reach resolution on labeling topics.
Education and Experience:
Bachelor's degree in scientific or medically-related field. Master's degree in scientific or medically-related field preferred.
Minimum of five years experience in the pharmaceutical industry, including regulatory experience and 8 or more years in work experience.
Sanofi Genzyme
Cambridge, MA
As the specialty care global business unit of Sanofi, we are focused on rare diseases, rare blood disorders, multiple sclerosis, oncology and immunology. More than 30 years since we began, we remain just as committed to and passionate about advancing therapies that offer hope to patients and families.
Our approach is shaped by a long history of developing highly specialized treatments and forging close relationships with physician and patient communities. Founded as Genzyme in Boston in 1981, we rapidly grew to become one of the world’s leading biotechnology companies, recognized for our pioneering development of treatments for rare genetic disorders and our innovative contributions to medical science and biomanufacturing.
Genzyme became part of Sanofi in 2011. While continuing to focus on rare diseases, we also established ourselves as a leader in the field of multiple sclerosis. In 2016, our focus expanded to include Sanofi’s programs in oncology and immunology. In 2018, with the acquisitions of Bioverativ and Ablynx, we further expanded our focus to include rare blood disorders, bringing deep expertise in hematology.
Our ambition is to be the industry leader in specialty care. We currently provide more than 25 treatments to patients globally, with many potential new therapies being studied in clinical trials and in Sanofi laboratories.
Driven by our commitment to patients, we strive to develop strong relationships with our patient communities, listening to their perspectives so that we can truly understand their needs. These collaborations continue to guide and motivate us as we work to push the boundaries of medicine and technology to develop new and better therapies where none existed before.
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IndustryBiopharmaceuticals
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No. of Employees14,000+
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Website
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Jobs Posted207
