What are the responsibilities and job description for the Global Regulatory Affairs Manager position at Actalent?
Description
• Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
• Responsible for relevant submissions for assigned program(s).
• Represent the Global Regulatory Sciences function on cross functional teams
• Support line manager in developing and implementing long and short-term product regulatory strategies/plans
• Plan for and lead preparation efforts for health authority meetings
• Provide guidance to external vendors and consultants as needed
• Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs
Additional Skills & Qualifications
• Bachelor’s degree in scientific discipline; advanced scientific related degree a plus
• 4 years or more in drug development; direct Regulatory experience is a plus
• Experience in oncology/rare diseases drug development a plus
• Ideally experienced in filing and managing INDs to FDA
• Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plus
Pay and Benefits
The pay range for this position is $75.00 - $75.00/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 Cambridge,MA.
Application Deadline
This position is anticipated to close on Aug 22, 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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
Salary : $75
