Senior Manager Regulatory Operationns

Company: Actalent
Location: South San Francisco
Posted on: February 18, 2026

Job Description:

Job Description Job Description Sr. Manager Regulatory Operations 2 Days on site in South San Francisco OR 2 Days on site in SD Job Description Collaborate with the Director of Regulatory Operations to oversee global regulatory submission processes, electronic publishing, and regulatory systems management, focusing on Regulatory Information Management (RIM) systems. Drive regulatory submission excellence, process optimization, and system innovation, ensuring timely execution of regulatory filings across multiple health authorities, including FDA, EMA, Health Canada, MHRA, and other global agencies. Serve as a subject matter expert in Veeva RIM, accountable for Common Technical Document (eCTD) submissions, global regulatory compliance, and document management best practices. Responsibilities Manage regulatory submission planning, publishing, and execution for global regulatory filings, including INDs, CTAs, and future NDA/MAA submissions. Support regulatory operations infrastructure, including eCTD publishing, document content templates, and Regulatory Information Management (RIM). Manage timelines and resources for all regulatory submissions, ensuring alignment with program goals and regulatory strategy. Support the implementation and continuous improvement of regulatory systems and processes (e.g., RIM, Publishing). Maintain regulatory submission archives. Essential Skills Bachelor’s degree in life sciences or equivalent. 7 years of experience in Regulatory Operations within the biotech or pharmaceutical industry, focusing on clinical-stage programs. Deep experience with eCTD publishing and global submission management (IND, CTA, BLA/NDA, MAA). Strong knowledge of global regulatory requirements (FDA, EMA, ICH). Proven experience working in a fast-paced, dynamic environment. Excellent project management and cross-functional collaboration skills. Proficiency with regulatory systems. Additional Skills & Qualifications Experience with Veeva RIM. Work Environment This role requires onsite presence two days a week at either the SSF or SD location. 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 $95.00 - $115.00/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 Feb 26, 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 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.

Keywords: Actalent, North Highlands , Senior Manager Regulatory Operationns, Science, Research & Development , South San Francisco, California