Regulatory Manager

Regulatory Manager (Part-Time Contractor) Location: South San Francisco (hybrid) Duration: 6-month contract with potential for extension Hours: Minimum 20 hours per week guaranteed Position Overview Our client is seeking a Regulatory Affairs Manager (contractor) to support the development of submission strategy and health authority responses for assigned studies, under the direction of the Regulatory Affairs Lead. This individual will be responsible for the review of regulatory documents and applications in compliance with applicable guidelines and regulations. The ideal candidate will blend detail-oriented execution (RIM systems, submissions, document review) with the ability to step up, take ownership, and contribute to broader regulatory efforts within a fast-moving team environment. Strong communication skills, leadership potential, and the ability to collaborate cross-functionally are critical for success. The hybrid aspect of the role will allow face-to-face interaction with project teams and SMEs as well as general execution support and training. Key Responsibilities Support responses to health authority requests for information or queries Review regulatory documents including, but not limited to: Protocols Investigator's Brochures (IBs) DSURs IMPDs Attend project team meetings and actively participate in: Global Regulatory Project Team (GRPT) Clinical Strategy Team (CST) Co‑lead regulatory workstreams (e.g., briefing book development, document review) Conduct disease precedence research Provide submissions and archiving support Prepare presentation slides and type meeting minutes for regulatory meetings Work closely with the Regulatory Affairs Lead and cross‑functional team members to support pipeline regulatory activities Support development of submission strategy and health authority responses Develop and maintain regulatory intelligence and share relevant updates with the Regulatory function Conduct periodic Veeva Vault updates for RIM and RIM Archives (3x/year) Assist in assessment of regulatory SOPs Ensure the Regulatory Submission Tracker is updated and identify any delayed submissions Maintain regulatory archives and health authority trackers, including: Monthly FDA submissions for all INDs (currently 6 INDs) Global health authority communications Ensure archives are complete in collaboration with a previous partner company Perform other duties as assigned Required 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 (sponsor) setting Prior experience reviewing core regulatory documents (e.g., Protocols, IBs, DSURs) Experience supporting regulatory submissions, document review, and RIM systems Hands‑on experience with Veeva Vault or a similar Regulatory Information Management (RIM) system Working knowledge of regulatory requirements (ICH guidance, FDA, EMA regulations) Experience with regulatory designations (e.g., ODD, Fast Track, Breakthrough Therapy Designation, PRIME) Experience completing Form 1571 and drafting regulatory cover letters Strong organizational skills with a focus on delivering quality results Ability to manage multiple projects with tight timelines Core Competencies Excellent verbal and written communication skills Strong interpersonal skills and ability to collaborate across cross‑functional teams, external vendors, and stakeholders Detail‑oriented with strong execution capabilities Leadership potential with ability to take ownership of workstreams Self‑motivated with a positive, "roll up your sleeves" attitude Ability to work effectively in a fast‑paced, start‑up environment 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 Jun 26, 2026. #J-18808-Ljbffr