Senior Director, Regulatory Operations
March 13
🏢 In-office - Bay Area
Description
• Define the strategic goals and direction for the Regulatory Operations group • Direct the activities of the Regulatory Operations group • Manage all Regulatory Operations submissions, systems related projects, and submission compliance • Lead Regulatory technology projects and maintain project times and reports • Proactively follow advancements in the technology field and propose strategies • Manage internal and external publishing staff • Develop, refine, and implement internal processes, procedures, work instructions, and training programs • Contribute to the main budget and forecasts for Regulatory Affairs • Work on all aspects of planning, creating, publishing, submitting, and archiving of regulatory submissions • Ensure consistency, completeness, and adherence to standards for all regulatory submissions • Lead the training of appropriate R&D staff in the application of various standards and technologies • Oversee RA compliance and quality activities as key partner for Quality Assurance • Perform other duties as assigned
Requirements
• Bachelor’s degree required; advanced degree preferred • 12+ years’ experience in a fast-paced, high-volume document production environment • Strong leadership skills • Experience in coaching and managing others • Expert knowledge of regulatory submission publishing standards and procedures • Strong communication, strategic thinking, and problem-solving skills • Robust understanding of evolving Health Authority (HA) standards and procedures • Overall understanding of drug development and business processes • Ability to meet tight competing deadlines, juggle multiple priorities, and multi-task
Benefits
• Salary range from $230,000 - $280,000 USD annually • Bonus • Benefits • Participation in Company’s stock option plan
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