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
