Regulatory Affairs Quality Control

1 week ago


Bothell, Washington, United States I3 INFOTEK INC Full time

Job Title: Regulatory Affairs Quality Control

Location: Bothell, WA

Local candidate preferred

LinkedIn Mandatory

Job Description:

Position Summary:

Team is seeking a Regulatory Affairs Contractor to contribute to the development and execution of effective regulatory strategies for investigational products. The successful candidate will serve as a regulatory contact within an internal matrixed team environment.

Principal Responsibilities:

  • Execute integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
  • Provide support to assigned clinical study and global regulatory teams.
  • Assess regulatory program risks for likelihood and impact; help to establish mitigation strategies.
  • Plan and prepare submissions to regulatory authorities, related to IND maintenance.
  • Advise on regulatory requirements, expected outcomes, and changes to landscape.
  • Strong information seeking skills and ability to work under moderate supervision.

ORGANIZATIONAL RELATIONSHIPS:

This person will interact with regulatory colleagues and matrixed project teams that may include clinical, medical, statistics, regulatory publishing and submissions, quality/CMC, medical writers, and other functions as needed.

EDUCATION AND EXPERIENCE:

  • Bachelor's degree in a life sciences discipline
  • 3+ years of relevant regulatory experience with drug or therapeutic biologic products required
  • Must have Oncology experience required
  • Must have General knowledge of the drug development process and US regulatory requirements, including expedited development programs for drugs to treat serious conditions

TECHNICAL SKILLS REQUIREMENTS:

  • Strong verbal and written communication skills.
  • Strong organizational skills, ability manage conflicting priorities and adhere to tight timelines
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail


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