Principal Regulatory Affairs Consultant

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🕒 Junho 2

🇺🇸 Estados Unidos – Remoto (EUA)

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Syner-G BioPharma Group

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Syner-G BioPharma Group é a principal fornecedora mundial de soluções em química, manufatura e controle (CMC), relações regulatórias e redação médica para o setor biofarmacêutico. Oferecem serviços abrangentes que guiam os clientes através das complexidades do desenvolvimento farmacêutico, submissões regulatórias e conformidade de qualidade, garantindo resultados de alta qualidade. Com uma equipe multidisciplinar, a Syner-G integra ciência, engenharia e expertise regulatória para apoiar o desenvolvimento de medicamentos desde a fase pré-IND até as fases pós-aprovação, permitindo submissões tempestivas e aderência à segurança do paciente.

Descrição

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. • Handle FDA Type A, Type B, and Type C meetings. • Engage in all phases of drug development, from early-stage to post-registration. • Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. • Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality. • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines. • Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements. • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement. • Serve as the main point of contact for clients, ensuring effective communication and regulatory support. • Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes. • Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions. • Partner with clients on Non-Clinical/Clinical strategy and submissions. • Evaluate proposed manufacturing and quality changes for impact on existing registrations. • Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

🎯 Requisitos

• Bachelor’s degree in chemistry, pharmaceutics, biology, or a related scientific discipline; MA degree preferred. • RAC Certification is a significant advantage; equivalent certifications or extensive experience in regulatory affairs are highly valued.

🏖️ Benefícios

• flexible paid time off • company-paid holidays • flexible working hours • remote work options for most roles