Regulatory Affairs Specialist

2 weeks ago

Bothell, Washington, United States Aequor Full time

Job Title: Regulatory Affairs

Contractor Work Location: Bothell, WA 98021 - Hybrid role - 3 days onsite , 2 days remote - locals only

Duration: 12 months contract

Interview Process: Phone Teams Bridge (Camera-On)

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.


• 2+ years of relevant regulatory experience with drug or therapeutic biologic products required.


• Oncology experience preferred.


• 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

PHYSICAL POSITION REQUIREMENTS:

This position may require sitting/standing, focusing on computer screen for long periods of time and interacting with colleagues.

Hard Skills:

1. 2+ years relevant experience.

2. Strong verbal and written communication skills.

3. Strong organizational skills, ability manage conflicting priorities and adhere to tight timelines.

4. Proven ability to work with a high level of integrity, accuracy, and attention to detail.

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