Oferta de trabajo: Regulatory Affairs

Job Title: Safety and Regulatory Specialist

Location: Bothell, WA

Hours/Schedule: Full-time

Compensation: $45-50/hr

Type: Contract

Overview:

The Safety & Regulatory Contractor will contribute to the development and execution of effective regulatory strategies for investigational products. This individual will serve as a regulatory contact within an internal matrixed team environment, ensuring compliance and strategic alignment across projects. This position will interact with regulatory colleagues and matrixed project teams, including clinical, medical, statistics, regulatory publishing and submissions, quality/CMC, medical writers, and other functions as needed.

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 the regulatory landscape.

• Collaborate with cross-functional teams, including clinical, medical, statistics, regulatory publishing and submissions, quality/CMC, and medical writing.

Requirements:

• 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 treating serious conditions.

• Strong verbal and written communication skills.

• Strong organizational skills with the 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.

Ref: #568-Clinical

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.