Job Information
Actalent Regulatory Affairs Specialist in Bothell, Washington
Job Title: Regulatory Affairs Specialist
Job Description
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.
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.
Demonstrate strong information seeking skills and ability to work under moderate supervision.
Essential Skills
Bachelor's degree in a life sciences discipline.
2+ 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.
Additional Skills & Qualifications
- Oncology experience preferred.
Pay and Benefits
The pay range for this position is $40.00 - $45.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision• Critical Illness, Accident, and Hospital• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available• Life Insurance (Voluntary Life & AD&D for the employee and dependents)• Short and long-term disability• Health Spending Account (HSA)• Transportation benefits• Employee Assistance Program• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a hybrid position in Bothell,WA.
Application Deadline
This position is anticipated to close on Mar 31, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
Hiring diverse talent
Maintaining an inclusive environment through persistent self-reflection
Building a culture of care, engagement, and recognition with clear outcomes
Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.