Regulatory Affairs Specialist
Listed on 2025-11-27
-
Healthcare
Safety and Regulatory Quality Control (Contract)
Bothell, WA, United States (Hybrid)
Contract (11 months 29 days)
Published 8 months ago
CLOSED
biologic products
regulatory affairs
regulatory strategies
regulatory documentation
US regulatory requirements
Regulatory Requirements
Oncology
Regulatory Compliance
Regulatory Affairs Specialist
Summary:
The Pfizer team is seeking a Regulatory Affairs Specialist 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.
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.
Qualifications:
- Bachelor's degree in a life sciences discipline
- A minimum of 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
- 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
Location/Schedule:
- This is a hybrid role in Bothell, WA; hybrid schedule pending
Contracts are engaged to provide services to Pfizer on a temporary basis in connection with a specific assignment. Contractors are hired and employed through Atrium, our third-party payrolling partner.
This job posting is for a temporary role as an employee of Atrium on assignment individual selected for this role will be offered the role as an employee of Atrium; compensation, medical benefits, fringe benefits and other terms and conditions of employment shall be presented by Atrium upon offer. The pay rate range provided is a reasonable estimate of the anticipated compensation range for this job at the time of posting.
The actual pay rate will be based on a number of factors, including skills, competencies, experience, location and/or being pursued and other job-related factors permitted by law. In addition, this role will be eligible for overtime pay, in accordance with federal and state requirements.
Pay Rate Range
Min Pay Rate $44
Max Pay Rate $54
Currency USD
Unit hourly
Benefits Information
Comprehensive Benefits Package available based on eligibility
- Short-Term Disability (STD)
- Long-Term Disability (LTD)
- Supplemental and Voluntary Life Insurance
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