TIME REGULATORY AFFAIRS MANAGER
- 20 HOURS A WEEK
- This contract role focuses on supporting the development of regulatory submission strategies, preparing and coordinating responses to health authorities, and reviewing key regulatory documents under the direction of a Regulatory Affairs Lead.
The position requires close collaboration with cross-functional teams, collaboration partners, and external vendors to ensure high-quality submissions and compliance with global regulatory guidelines and regulations. The successful candidate will blend strong operational execution in regulatory systems and documentation with leadership potential and proactive ownership in a fast-moving team environment. Responsibilities Support the development of regulatory submission strategies for assigned studies under the direction of the Regulatory Affairs Lead. Help prepare and coordinate responses to health authority requests for information and queries. Review regulatory documents, including but not limited to clinical study protocols, Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), and other core regulatory documents. Participate in global regulatory project teams and clinical strategy teams to align regulatory activities with clinical and development plans. Work closely with the Regulatory Affairs Lead and cross-functional team members to support regulatory activities across the pipeline. Develop and maintain up-to-date regulatory knowledge and intelligence, and proactively share relevant developments with the regulatory function. Conduct periodic updates in Veeva Vault for Regulatory Information Management (RIM) and RIM Archives three times per year. Assist in the review and assessment of regulatory standard operating procedures (SOPs). Ensure the regulatory submission tracker is updated regularly, including noting any delays in planned submissions. Maintain complete and accurate regulatory archives and trackers, including monthly FDA submission records for all INDs and global health authority communications, and coordinate with partners to ensure archival completeness. Attend project team meetings and contribute regulatory input to discussions and decision-making. Conduct disease precedence and background research to support regulatory strategies and submissions. Provide submissions and archiving support, including preparation, coordination, and documentation of regulatory filings. Prepare presentation slides and other materials for regulatory and project team meetings. Draft and type up meeting minutes, ensuring key decisions, action items, and timelines are accurately documented. Co-lead regulatory workstreams such as briefing book development, document review cycles, and other submission-related activities. Complete and manage Form FDA 1571 and associated cover letters for regulatory submissions. Support regulatory activities related to special regulatory designations, including Orphan Drug Designation (ODD), Fast Track, Breakthrough Therapy Designation (BTD), PRIME, and similar programs. Perform other regulatory duties as assigned to support the broader regulatory function and project needs. Essential Skills Minimum of 5 years of regulatory affairs experience in an industry or clinical research organization setting. Bachelor's degree in a life science discipline from an accredited college or university. Prior experience reviewing clinical protocols, Investigator's Brochures (IBs), and other core regulatory documents. Hands-on experience completing Form FDA 1571 and drafting associated cover letters for submissions. Experience supporting or managing regulatory designations such as Orphan Drug Designation (ODD), Fast Track, Breakthrough Therapy Designation (BTD), and PRIME. Prior experience working with Veeva Vault or a similar Regulatory Information Management (RIM) system. 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. 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 South San Francisco,CA.
Application Deadline This position is anticipated to close on Jul 1, 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.
