Regulatory Manager - 100% REMOTE
Position Summary
Regulatory Affairs Associate Manager/ Manager that will be responsible for supporting the development of submission strategy and health authority responses for assigned studies and the review of regulatory documents/applications under the direction of the Regulatory Affairs Lead, in compliance with guidelines and regulations. The contractor should be able to effectively collaborate with cross-functional representatives, collaboration partners, external vendors, and stakeholders while maintaining a positive team environment.
Position Responsibilities
• Help support responses to health authority request for information or queries
• Review of regulatory documents including but not limited to Protocol, IB, DSUR, IMPD.
• Active participation in global regulatory project team (GRPT) and the clinical strategy team (CST).
• Work closely with the Regulatory Affairs Lead and cross-functional team members to support the regulatory activities in the pipeline
• Develop and maintain regulatory knowledge and intelligence and share relevant developments in the field to the Regulatory function
• Conduct Veeva Vault periodic updates for RIM and RIM Archives (3x/year).
• Assist in assessment of regulatory SOPs.
• Ensure the Regulatory Submission Tracker is updated regularly, and note any planned submissions that are delayed
• Keep regulatory archives and HA trackers updated with monthly FDA submissions for all INDs (currently 6 INDs) and global health authority communications, as received. Work with AbbVie to ensure our archives are complete.
• Other duties as assigned
Additional Skills & Qualifications
• Bachelor’s degree in a life science discipline from an accredited college or university. Advanced degree, Master’s, PharmD or PhD preferred.
• Minimum of 5 years of regulatory affairs experience in an industry or clinical research organization setting.
• Prior experience working in Veeva Vault platform or similar Regulatory Information Management (RIM) system.
• Working knowledge of Regulatory requirements (e.g., ICH guidance, FDA, and EMA regulations)
• Excellent organization skills with a passion for delivering quality results
• Ability to work on a number of projects with tight timelines
• Strong interpersonal skills to build and maintain positive working relationships
• Detail-oriented mindset with excellent verbal and written communication skills
• Self-motivated and able to work collaboratively
• Ability to “roll up sleeves” in a start-up environment and a positive can-do attitude
Experience Level
Intermediate Level
Job Type & Location
This is a Contract position based out of South San Francisco, CA.
Pay And Benefits
The pay range for this position is $60.00 - $96.00/hr.
Requirements
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 fully remote position.
Application Deadline
This position is anticipated to close on Jun 19, 2026.
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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
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 for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.