Regulatory Associate
Actalent
Job Title: Regulatory Associate
Job Description
We are seeking a dedicated Regulatory Associate to join our oncology department. The successful candidate will support a specific disease group and focus primarily on maintenance activities. This role involves handling regulatory activities for assigned disease groups and assisting with varying workloads across teams. You will be supporting an average of 30 trials, primarily in phases 2-4. Our team values collaboration and provides a welcoming environment for new members.
Responsibilities
+ Support a specific disease group within the oncology department.
+ Focus on regulatory maintenance activities.
+ Handle IRB submissions to local and central IRBs (Advarra and WCG).
+ Manage regulatory documents including amendments, financial disclosures, delegation of authority logs, etc.
+ Support an average of 30 clinical trials in phases 2-4.
+ Assist other disease groups as needed to balance workloads.
Required Skills/Experience
+ Experience in regulatory affairs and clinical research.
+ Proficiency with IRB submissions and regulatory documents.
+ Knowledge of oncology regulatory requirements.
+ Experience with regulatory submissions and handling IRB-related tasks.
Pay and Benefits
The pay range for this position is $25.12 - $41.25
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 Detroit,MI.
Application Deadline
This position will be accepting applications until Jan 24, 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.
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