KOB Solutions, Inc.

Associate Director, Regulatory Operations

KOB Solutions, Inc. Waltham, MA
KOB Solutions, Inc.

Associate Director, Regulatory Operations

KOB Solutions, Inc. Waltham, MA
1 month ago 39 applicants

See who KOB Solutions, Inc. has hired for this role

fully remote

Main Responsibilities

  • Manage the preparation of eCTD submission-ready documents and ensure quality, accuracy, and adherence to regulatory guidelines.
  • Prepare and submit INDs, CTAs, annual reports, DSURs, and safety reports to regulatory authorities.
  • Track and report submission activities, manage processes for archiving health authority correspondence and submissions, and ensure compliance with regulatory standards.
  • Support the regulatory team across all aspects of Regulatory Affairs related to the development of novel therapeutics, including nonclinical, clinical, and quality.
  • Plan and monitor regulatory activities, draft SOPs and work instructions, and identify best practices and regulatory precedents.
  • Collaborate with internal preclinical, clinical, CMC, and safety teams, to produce high-quality regulatory submission documents and ensure completion of IND submissions and amendments.

Essential Experience

  • Biologics development and oncology expertise.
  • 7+ years of experience in regulatory operations.
  • Extensive global regulatory experience with INDs/CTAs, BLAs/MAAs, lifecycle management, interactions with Health Authorities and working with project teams.
  • Experience implementing and maintaining document management systems.

Essential Qualifications

  • Attention to detail and accuracy in document preparation and submission.
  • Ability to be both strategic and operational, including hands-on and higher levels.
  • Exceptional organizational skills, effective verbal and written communication and interpersonal skills, and a team approach.
  • Strong business acumen and ability to make sound decisions that contribute positively to the business.
  • Self-motivated and able to work independently.

Additional Points

  • This is a fully remote role with quarterly travel to headquarters.
  • Competitive compensation package includes base salary + bonus + options.

  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Management and Manufacturing

  • Industries

    Staffing and Recruiting

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