Regulatory Affairs Specialist
Apply NowCompany: Katalyst HealthCares and Life Sciences
Location: Bothell, WA 98012
Description:
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.
- 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.