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The Senior Regulatory Affairs Specialist provides regulatory guidance to cross-functional teams; develops global regulatory strategies; advises on labeling and marketing materials for regulatory compliance; and evaluates product changes for impact on regulatory filings worldwide.
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At least five (5) years of experience involving the direct implementation of promotional labeling and advertising regulations in the biotech/pharmaceutical/medical device industry; this must include extensive experience providing regulatory input and evaluation as part of a promotional review committee.
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Knowledge or experience in protein higher-order structure characterization with mass spectrometry-based methods such a hydrogen/deuterium exchange, covalent labeling, or foot printing methods is highly desirable but not required.
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Previous demonstrated experience of global regulatory drug development to at least one major regulatory approval within a major market (US, EU) including leading the regulatory strategy, response team, and labeling negotiations.
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6+ years' experience in Drug Safety and Pharmacovigilance in pharmaceutical or biotech company, CRO or regulatory agency within Drug Safety/Pharmacovigilance, with both investigational and marketed products.
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Reporting to the Senior Director, Regulatory Affairs, Advertising, Promotion & Labeling, the Director, Regulatory Affairs, Advertising and Promotion will be responsible for providing sound regulatory advice related to communication of information related to assigned Alkermes products and disease areas.
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Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials, including representation on global regulatory and labeling teams.
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Acceptable and independent skills in the area of regulatory affairs such as understanding broad concepts within labeling and implications across the organization and globally; proactively identify issues; offers creative solutions and strategies, including risk mitigation strategies.
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Provide a leadership role on the review committee (RC) by providing regulatory guidance on promotional labeling and advertising materials. Provide regulatory leadership and guidance to Commercial teams during the development, review and approval of product labeling and advertising materials.
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Communicate effectively and transparently with functional heads within pharmaceutical development and other company stakeholders (Quality, Toxicology/DMPK, Clinical/Regulatory, Operations, Project, etc.
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Responsible for review/approval of Document Change Orders (DCOs), Design Change requests and labeling; including assessments of regulatory impact. Works with R&D on product V&V activities including sterilization, packaging/labeling, transit testing, real time/accelerated aging as well as review and approval of engineering protocols and reports.
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Lead a Global Regulatory Strategy Team (GRST) of key contributing members from the regions, emerging markets, RA CMC, Labeling and members of the submission and execution team. Lead preparation of the regulatory strategy document and target product labeling.
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Review and approve advertising, promotional items and labeling for regulatory compliance. regulatory affairs specialist (cambridge). Bachelors degree or equivalent internationally-acquired qualifications preferably in Regulatory Affairs and/or a science related field or equivalent experience in the medical device industry.
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Provides regulatory review of advertising and promotional labeling, disease awareness and training materials, new campaigns, and product launch strategies. The Associate Director, Regulatory Affairs Advertising & Promotion will be responsible for providing strategic, operational and tactical regulatory advice to internal stakeholders regarding communications about investigational product pipeline assets and approved prescription products ensuring they comply with US laws and regulations and company policies, while supporting achievement of business objectives.
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Student seeking a Bachelors or Masters degree in regulatory affairs. Assist in drafting, organizing, and editing regulatory documents for. Assist in product labeling reviews to meet US labeling requirements.
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labeling regulatory jobs in Cambridge, MA
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