Regulatory Affairs Specialist

5 days ago


Bothell, Washington, United States Katalyst HealthCares and Life Sciences Full time
Responsibilities:
  • We are 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.
  • Execute integrated regulatory plans that deliver against strategic objectives, maintain compliance, and protect patients.
  • Provide support to assigned clinical study and global regulatory teams.
  • ssess regulatory program risks for likelihood and impact; help to establish mitigation strategies.
  • Plan and prepare submissions to regulatory authorities, related to IND maintenance.
  • dvise on regulatory requirements, expected outcomes, and changes to landscape.
  • Demonstrate strong information seeking skills and ability to work under moderate supervision.
  • Building a culture of care, engagement, and recognition with clear outcomes.
Requirements:
  • Bachelor's degree in a life sciences discipline.
  • 5 years of relevant regulatory experience with drug or therapeutic biologic products.
  • General knowledge of the drug development process and US regulatory requirements, including expedited development programs for drugs to treat serious conditions.
  • Strong verbal and written communication skills.
  • Strong organizational skills, ability to manage conflicting priorities and adhere to tight timelines.
  • Proven ability to work with a high level of integrity, accuracy, and attention to detail.
  • Maintaining an inclusive environment through persistent self-reflection.


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