Senior Regulatory Affairs Consultant

🕒 Outubro 22

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

🚔 Conformidade

👻 Score fantasma 10%

O que significa: a chance de ninguém estar realmente contratando para esta vaga.Como ler: 60% ou mais significa que achamos que é uma vaga fantasma. Pontuações mais baixas preocupam menos.Por que essa pontuação:

• Aberta há 19 dias.
• As vagas desta empresa costumam ser preenchidas em 21 dias.
• Sem salário divulgado.

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ProductLife Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

💼 Consultoria

🏥 Saúde

💊 Farmacêutico

💰 GROWTH EQUITY VC em 2024-04

Consulting • Healthcare • Pharmaceuticals

A ProductLife Group é uma empresa global de consultoria e outsourcing em life sciences que combina profunda expertise humana com automação inteligente para ajudar a levar terapias e produtos de saúde do desenvolvimento ao acesso dos pacientes. A empresa oferece soluções end-to-end em desenvolvimento de produtos (da fase pré-clínica à aprovação), assuntos regulatórios, CMC e qualidade, desenvolvimento clínico, engenharia e construção de instalações, acesso ao mercado e aos pacientes, segurança e compliance, além de inovação digital e habilitada por IA. A ProductLife Group atende clientes dos setores biofarmacêutico, de medtech e de saúde do consumidor, opera uma rede global de escritórios com cobertura em mais de 150 países e reúne cerca de 1. 750 especialistas, processando mais de 10 mil submissões por ano.

Descrição

• Serve as a senior regulatory advisor and Regulatory Lead for biotechnology and pharmaceutical client engagements • Develop, refine, and execute regulatory strategies aligned with client development objectives, regulatory milestones, and submission plans • Lead complex, multidisciplinary regulatory projects and programs by defining workplans, timelines, budgets, assumptions, resource requirements, and delivery approaches • Lead, coordinate, author, and review key regulatory documents, including Health Authority meeting packages and briefing documents, special designation requests, INDs, NDAs, BLAs, CTAs and amendments, responses to Health Authority questions, and regulatory correspondence • Support, lead, or participate in formal interactions with Health Authorities on behalf of clients • Develop meeting strategies and prepare and coach clients for Health Authority meetings • Serve as Authorized Sponsor Representative when required • Interpret and apply FDA, Health Canada, ICH, GxP, and global regulatory guidance, requirements, industry standards, and precedents • Coordinate cross-functional client and internal teams, including Clinical, CMC, Nonclinical, Quality, Regulatory Operations, Medical Writing, and Program Management • Oversee multiple regulatory workstreams and ensure alignment across submissions, deliverables, decisions, and timelines • Monitor project progress and identify regulatory, operational, resourcing, timeline, and client-delivery risks • Develop risk-mitigation plans and communicate project status to clients and internal stakeholders • Contribute regulatory expertise to project scoping, proposals, statements of work, budget assumptions, timelines, and resource planning • Support business development by presenting PLG's regulatory capabilities and identifying opportunities for continued or expanded client partnerships

🎯 Requisitos

• Bachelor's degree in life sciences, pharmacy, biology, chemistry, regulatory affairs, public health, or another relevant scientific discipline • Advanced degree and/or regulatory certification preferred but not required • Minimum of 10–12 years of progressive Regulatory Affairs experience within biotechnology and pharmaceuticals, or life sciences consulting • Experience developing and executing regulatory strategies for development-stage programs, ideally from early development through registration or marketing approval • Experience leading or supporting Health Authority interactions, including FDA and/or ex-U.S. agency meetings, briefing packages, responses, and regulatory correspondence • Experience authoring, reviewing, coordinating, or leading major regulatory submissions, such as INDs, NDAs, BLAs, CTAs, amendments, special designation requests, and Health Authority meeting packages • Strong knowledge of FDA and global regulatory guidance, ICH expectations, GxPs, and relevant industry trends • Strong project and program management capabilities, including timeline ownership, workstream coordination, budget and resource awareness, risk identification, and mitigation planning • Demonstrated ability to coordinate cross-functional teams and manage multiple regulatory deliverables, workstreams, timelines, and competing priorities

🏖️ Benefícios

• Career growth opportunities • Opportunity to make a meaningful impact on global healthcare • Work with an innovative, forward-thinking global team • Purpose-driven work • Remote work arrangement

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