Source Job

• Co-ordinate and compile regulatory submissions and agency correspondence for assigned projects
• Implement action plans to achieve timely approval of submissions ensuring compliance
• Participate in and support project teams to achieve regulatory goals

Jobgether is acting as a job platform partnering with other companies. They utilize an AI-powered matching process to ensure fair application reviews, identifying top candidates for client companies, though final hiring decisions are managed by the client's internal team.

• Provides regulatory guidance throughout the clinical development life cycle
• Compile, coordinate and review applications to Regulatory Authorities
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees

Precision for Medicine integrates clinical trial execution with scientific knowledge, lab expertise, and data science to improve the speed, cost, and success rate of life-changing therapies. They focus on Oncology and Rare Disease and value employee contributions.

• Provides regulatory guidance throughout the clinical development life cycle.
• Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards.
• Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers

Precision for Medicine integrates clinical trial execution with scientific knowledge, laboratory expertise, and data sciences, focusing on Oncology and Rare Disease. The company values employee contributions and nurtures ideas, striving for positive change.

• Maintain current knowledge of applicable laws and regulations.
• Interpret regulatory requirements for products and ensure compliance.
• Participate as a regulatory representative on project teams.

Kansas General focuses on developing and implementing long-range regulatory strategies. The job posting does not mention the company size or culture.

• Strategize, plan, and author regulatory plans and activities to optimally position GRAIL products with the FDA and/or global health authorities.
• Support the U.S. Regulatory Affairs team in preparing submissions such as PMAs, 510(k)s, post-approval reports, annual reports, export certificates, establishment registrations, and device listings.
• Serve as a key member of the Regulatory team, offering insights and solutions on corporate product portfolios and strategies.

GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. They have built a multi-disciplinary organization of scientists, engineers, and physicians and are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.

• Build and mature core elements of Rula’s enterprise Compliance Program.
• Ensure adherence to federal and state healthcare regulatory requirements across Rula’s clinical operations.
• Lead compliance risk assessments and internal controls; oversee investigations and corrective action processes.

Rula is dedicated to treating the whole person and aims to create a world where mental health is no longer stigmatized. Rula is a remote-first company that is passionate about making a positive impact on the lives of those struggling with mental health issues.

• Advise on regulatory compliance matters across jurisdictions.
• Support business units on pharmacy operations and supply chain issues.
• Assist with responses to regulatory inquiries and complaints.

Hims & Hers is a health and wellness platform that aims to improve people's health through accessible care. They are a public company traded on the NYSE with a talent-first flexible/remote work approach.