Regulatory Compliance Manager

Job Title: Regulatory Compliance ManagerThe Regulatory Compliance Manager provides compliance oversight for Global Patient Safety (GPS) and Regulatory Affairs (RA), with a primary focus on Regulatory Affairs activities within the pharmaceutical industry. This role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators, metrics, and inspection readiness standards.The position drives process standardization and consistency by leading compliance monitoring activities, proactively identifying compliance and operational risks, and advancing continuous improvement initiatives. Working cross-functionally with Clinical Operations, Clinical Development, Quality Assurance, and other stakeholders, this role supports alignment with regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness.ResponsibilitiesEnsure the accuracy of Reference Safety Information (RSI) trackers, including timely updates of submission dates and health authority approvals.Track Requests for Information (RFIs) to completion within required timelines in accordance with standard operating procedures (SOPs).Monitor aggregate report compliance to health authorities and contract research organizations (CROs).Collaborate with Regulatory Affairs Strategists, CROs, and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM remain current, accurate, and complete for Regulatory Affairs–related documents.Monitor Regulatory Affairs training compliance using the learning management system (LMS) and other relevant tools.Oversee the timely and accurate update of Regulatory Affairs SOPs by partnering with SOP owners and ensuring documents reflect current regulatory and procedural expectations.Ensure Regulatory Affairs points of contact for each study remain current and accurate with health authorities.Monitor and analyze key compliance metrics to assess adherence to applicable procedures, regulations, and internal standards.Contribute to the development of leadership dashboards and presentation materials that summarize compliance performance, trends, and inspection readiness.Essential SkillsBachelor’s degree in a related discipline and a minimum of 5–7 years of related experience, or a Master’s degree in a related discipline and a minimum of 3–5 years of related experience, or an equivalent combination of education and experience.At least 5 years of Regulatory Affairs experience in the pharmaceutical industry.Strong knowledge of the regulatory framework, industry drivers, and Regulatory Affairs practices within the pharmaceutical sector.Demonstrated experience monitoring compliance metrics and inspection readiness standards.Experience working cross-functionally with Global Patient Safety, Regulatory Affairs, Clinical Operations, Clinical Development, and Quality Assurance.Proven ability to lead compliance monitoring activities and identify compliance and operational risks.Additional Skills & QualificationsExperience with audits and inspections in a pharmaceutical or regulated environment (preferred but not required).Experience with Global Patient Safety (GPS) and Regulatory Affairs (RA) quality, standards, and training functions.Familiarity with Veeva RIM or similar regulatory information management systems.Experience working with Trial Master Files (TMF) and coordinating with contract research organizations (CROs).Experience supporting or leading investigations of Quality Events, including root cause analysis and CAPA development.Experience contributing to leadership dashboards, metrics reporting, and compliance trend analysis.Experience authoring and maintaining training matrices and aligning training requirements with regulatory expectations.Demonstrated ability to develop innovative approaches to complex regulatory and compliance challenges.Confidence in speaking in one-to-one and group settings and presenting to cross-functional stakeholders.Ability to consider longer-term implications of regulatory decisions and actions when planning and executing work.Work EnvironmentThis role operates in a professional pharmaceutical and regulatory environment and may be performed remotely within the Pacific Time Zone (PST) or on-site in Alameda, California. The position involves regular collaboration with cross-functional teams such as Global Patient Safety, Regulatory Affairs, Clinical Operations, Clinical Development, Quality Assurance, and Corporate Training, primarily through virtual meetings, digital collaboration tools, and document management systems. Work typically requires extended use of computers and specialized regulatory systems such as Veeva RIM and learning management systems. The schedule generally aligns with standard business hours in the PST time zone, with flexibility to support global stakeholders and health authority interactions as needed. The environment emphasizes continuous inspection readiness, adherence to regulatory standards, and high-quality documentation, with a strong culture of collaboration, accountability, and continuous improvement.Job Type & LocationThis is a Contract position based out of Alameda, CA.Pay And BenefitsThe pay range for this position is $60.00 - $80.00/hr.RequirementsEligibility 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 TypeThis is a fully remote position.Application DeadlineThis position is anticipated to close on May 22, 2026.About ActalentActalent 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 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.