Regulatory Labeling Manager

🕒 4 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

🚔 Conformidade

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Syneos Health

SiteLinkedInTodas as Vagas

10.000+ funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

Syneos Health é uma organização líder, totalmente integrada, de soluções biofarmacêuticas, criada para acelerar o sucesso dos clientes. A empresa transforma insights exclusivos clínicos, de Assuntos Médicos (Medical Affairs) e comerciais em resultados para responder às realidades modernas do mercado. Ao utilizar tecnologias avançadas e insights, a Syneos Health colabora com os clientes para acelerar a entrega de terapias importantes a pacientes no mundo todo, oferecendo serviços que abrangem todo o espectro do clínico ao comercial.

Descrição

• The Regulatory Labeling Manager – Lifecycle Products is responsible for the development, maintenance, and oversight of labeling content for mature pharmaceutical products. • This role involves authoring and updating labeling documents in response to safety updates, regulatory requirements, and internal assessments. • The manager collaborates with internal stakeholders to ensure governance processes are followed and labeling decisions are well-documented in accordance with Vertex’s Labeling Procedures. • Plan and lead labeling updates driven by safety changes, regulatory commitments, and periodic reviews. • Author and revise labeling documents including the Company Core Data Sheets (CCDSs), US Prescribing Information (USPI), EU Summary of Product Characteristics (SmPC), and Rest of World (ROW) labels for lifecycle products. • Support labeling governance activities by collaborating with the team lead and GLL/RLL to prepare materials, attend the governance meeting and record accurate minutes in a timely manner to upload in the electronic document management system, and ensure required approvals are obtained. • Ensure labeling content complies with applicable regulatory requirements (e.g., FDA, EMA, ICH) and internal standards. • Collaborate with cross-functional teams (e.g., Safety, Medical, Legal, Regulatory Strategy) to gather input and align on labeling changes, as needed. • Support responses to health authority queries related to labeling content. • Partner with document specialists and publishing teams to ensure submission-ready formatting and timely delivery. • Attend labeling governance meetings and draft accurate minutes in a timely manner. • Upload minutes to the electronic document management system.

🎯 Requisitos

• Strong understanding of global labeling regulations and guidance (FDA, EMA, ICH). • Proven experience authoring and maintaining labeling content for approved products. • A strong command of English language including grammar, spelling, and punctuation and exceptional proofreading and editing skills. • Strong organizational skills and attention to detail. • Proficiency in Microsoft Word and document management systems (e.g., Veeva Vault). • Experience using Label tracking systems, e.g. Intagras, Veeva Labeling. • Ability to communicate and work effectively with labeling stakeholders.

🏖️ Benefícios

• We are passionate about developing our people, through career development and progression; supportive and engaged 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.