Manager, Regulatory Affairs in United States at Jobgether

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Manager, Regulatory Affairs in United States.

In this role, you will contribute to the advancement of innovative oncology therapies by supporting global regulatory strategy and execution across clinical and preclinical development programs. You will be responsible for ensuring the timely preparation and submission of high-quality regulatory documents in compliance with FDA, ICH, and other global health authority requirements. Acting as a key connector across cross-functional teams, you will help shape regulatory pathways that enable efficient drug development and approval processes. This position requires strong attention to detail, strategic thinking, and the ability to operate in a fast-paced, science-driven environment. You will also play an important role in identifying regulatory risks, supporting NDA filings, and ensuring alignment with evolving global regulatory standards. This is a fully remote role within the United States, offering the opportunity to contribute to cutting-edge oncology innovation.

• Lead the planning, preparation, coordination, and submission of regulatory documents to global health authorities in compliance with ICH and FDA standards
• Prepare and manage clinical and preclinical regulatory submissions, including IND applications, amendments, and related documentation
• Develop, author, and maintain regulatory submission content in eCTD format as required
• Support NDA filing activities and contribute to the development of associated regulatory strategies and processes
• Conduct regulatory research to assess implications and inform drug development and business strategy decisions
• Ensure accurate tracking of regulatory timelines and submission milestones to maintain operational continuity
• Identify, assess, and communicate regulatory risks across development programs
• Collaborate cross-functionally with scientific, clinical, and executive teams to support regulatory objectives
• Monitor changes in global regulatory frameworks (FDA, EMA, ICH, PMDA) and ensure ongoing compliance
• Support the development of regulatory tools, processes, and budget planning for efficient operations

Requirements:

• Bachelor’s degree in Regulatory Science, Life Sciences, Health Sciences, or related field with 3+ years of regulatory affairs experience in a pharmaceutical or biologics environment
• Alternatively, Master’s degree in a relevant field with at least 1 year of regulatory affairs experience
• Hands-on experience preparing and managing IND submissions and amendments
• Strong knowledge of eCTD submission standards and global regulatory filing processes
• Proven ability to interpret and apply FDA, ICH, EMA, and PMDA regulations in oncology or drug development contexts
• Experience managing global regulatory submissions and maintaining compliance across multiple jurisdictions
• Strong organizational skills with the ability to manage complex timelines and regulatory deliverables
• Excellent communication skills with the ability to collaborate across technical and executive stakeholders
• Strong analytical mindset and attention to detail in a highly regulated environment
• Ability to work independently in a remote, fast-paced, and cross-functional setting

Benefits:

• Competitive base salary range of $168,064 to $178,000 USD
• Additional total rewards including cash compensation, equity awards, and performance-based incentives
• Robust benefits package including healthcare and wellness support (varies by eligibility and location)
• Remote work flexibility across the continental United States
• Strong learning and professional development opportunities
• Exposure to advanced oncology drug development programs
• Inclusive and equal-opportunity work environment
• Opportunity to contribute to high-impact, patient-focused innovation