Senior Regulatory CMC Drug-Device Combination Product Lead

🕒 Agosto 7

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $111.000 - $149.000 / ano

⏰ Tempo Integral

🟠 Sênior

✅ Gerente de Produto

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Biogen

SiteLinkedInTodas as Vagas

5001 - 10000 funcionários

🏥 Saúde

🏭 Manufatura

🧬 Biotecnologia

Healthcare • Manufacturing • Biotechnology

A Biogen é uma empresa de biotecnologia dedicada à descoberta, desenvolvimento e fornecimento de terapias inovadoras para pessoas que vivem com doenças neurológicas graves, incluindo a doença de Alzheimer, esclerose múltipla e atrofia muscular espinhal. Com forte ênfase em pesquisa e desenvolvimento, a Biogen continua a avançar na ciência da neurologia por meio de ensaios clínicos e parcerias estratégicas, enquanto também se esforça para garantir acesso e equidade em saúde no setor de saúde.

Descrição

• Represent the Regulatory CMC Device function on cross-functional teams and provide regulatory guidance for combination products and medical devices • Author and coordinate regulatory documentation and submissions while ensuring compliance with applicable regulations • Lead or assist in project assignments supporting business needs, including representing Regulatory CMC in cross-functional work streams • Develop and execute regulatory strategies for medical devices and combination products, including new registration submissions and post-approval applications • Communicate CMC regulatory strategies, risks, and overall plans to leadership and cross-functional teams • Author, review, and approve CMC submissions and responses to Health Authority questions in alignment with global regulatory strategies and timelines • Collaborate with cross-functional teams to prepare submissions and responses to Health Authority CMC questions • Monitor and communicate legislative and regulatory developments in relevant areas • Participate in regulatory intelligence activities and trade organization working groups • Develop and enhance regulatory processes and procedures • Build strong internal relationships and deliver effective presentations to internal audiences

🎯 Requisitos

• Minimum of a bachelor’s degree (BS) • At least 5 years of regulatory experience, ideally in the medical device, pharmaceutical, or biotechnology industries • In-depth understanding of how regulatory functions within a business environment and interfaces with multiple functional areas • Experience in Medical Device and/or Combination Product Regulatory Affairs in a similar or junior role • Understanding of the application of cGMP for Medical Devices and Combination Products • Awareness of applicable legislation, regulations, guidance, and standards related to medical devices and combination products • Strong analytical abilities and attention to detail • Preferred: Degree in Life/Health Sciences or Engineering

🏖️ Benefícios

• Regular employees are eligible for short-term and long-term incentives, including cash bonus and equity incentive opportunities • Medical, Dental, Vision, & Life insurances • Fitness & Wellness programs including a fitness reimbursement • Short- and Long-Term Disability insurance • A minimum of 15 days of paid vacation • Additional end-of-year shutdown time off (Dec 26-Dec 31) • Up to 12 company paid holidays + 3 paid days off for Personal Significance • 80 hours of sick time per calendar year • Paid Maternity and Parental Leave benefit • 401(k) program participation with company matched contributions • Employee stock purchase plan • Tuition reimbursement of up to $10,000 per calendar year • Employee Resource Groups participation • Opportunities for learning, growth, and expanding skills