Regulatory Affairs Specialist

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $37 - $57 / hour

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

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Foundation

WebsiteLinkedInAll Job Openings

11 - 50 employees

₿ Crypto

🏪 Marketplace

🛍️ eCommerce

💰 $200k Seed Round on 2021-02

Crypto • Marketplace • eCommerce

Foundation is a platform that facilitates the buying and selling of NFTs (Non-Fungible Tokens). It provides a marketplace where artists and collectors can connect and trade digital artworks and collectibles, often expressed in Ethereum cryptocurrency. The platform features various trending and featured works, including exhibitions and galleries presented by different artists or collectives. Foundation Labs operates with a focus on the digital art community, providing a space for creators to showcase their work to a global audience.

📋 Description

• Prepare, review, compile, and support submission of regulatory documents for assigned research IND applications, including initial INDs, annual reports, protocol amendments, information amendments, and safety reports. • Support preparation of non-emergency use single-patient IND submissions. • Review investigator regulatory files and site documentation, including Form FDA 1572s, IRB approvals, and related documents, for accuracy, completeness, and compliance. • Assist with maintaining compliance with applicable regulatory requirements, institutional and departmental policies, FDA regulations and guidance, and GCP guidelines. • Maintain professional growth and development by participating in seminars, workshops, professional affiliations, and other learning opportunities to remain current with regulatory affairs practices. • Ensure compliance with applicable regulatory, departmental, institutional policies and FDA guidance rulings, as well as ensuring compliance with Good Clinical Practice (GCP) guidelines for research programs.

🎯 Requirements

• Bachelor's Degree in scientific discipline, regulatory affairs, or a related field with a minimum of 3-5 years of experience or a Masters/PhD in scientific discipline, regulatory affairs, or a related field with a minimum of 0-2 years of experience. • Experience within regulatory affairs or in a related FDA-regulated industry is required • Regulatory Affairs Certification (RAC) or other relevant regulatory certification is preferred • Excellent written, editorial and verbal communication skills. • Strong organizational skills and demonstrated ability to manage deadlines, competing priorities, and regulatory deliverables in a fast-paced environment. • Strong analytical, critical thinking, proofreading, and document review skills. • Working knowledge of FDA regulatory requirements and guidance related to INDs.

🏖️ Benefits

• Health insurance • Retirement plans • Paid time off • Flexible work arrangements • Professional development