Regulatory Affairs Quality/Standards/Training Manager - Remote

Regulatory Affairs Quality/Standards/Training Manager - Remote Ledgent Technology - 3.9 Alameda, CA Job Details Full-time | Contract $85.00 - $93.68 an hour 1 day ago Qualifications Pharmaceutical regulatory compliance Full Job Description We are seeking a Regulatory Affairs Quality, Standards and Training, Senior Manager to work on a remote team for a client project. The client is based in Alameda, CA, so supporting Pacific Time may be required. The role has the opportunity to become contract to hire, but the person in the role would need to be open to working onsite 5 days per week in Alameda, CA.

Duration:

6 months, could be extended

Pay Rate Range:

$85.00/hr. - $93.68/hr.

SUMMARY/JOB PURPOSE

The Regulatory Affairs Quality, Standards, and Training Senior Manager provides compliance oversight for the Global Patient Safety (GPS) and Regulatory Affairs (RA) function, with a primary focus on Regulatory Affairs activities. The role applies strong regulatory strategy knowledge to monitor, assess, and communicate performance against key compliance indicators, metrics, and inspection‑readiness standards. The Senior Manager 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, and Quality Assurance, the role supports alignment to regulatory standards, mitigates compliance risk, and strengthens organizational inspection readiness.

ESSENTIAL DUTIES/RESPONSIBILITIES

Ensure accuracy of Reference Safety Information (RSI) trackers to include timely updates of submission dates and health authority approvals. Track RFIs to completion within the timelines as required per SOP Monitor aggregate report compliance to health authorities and CROs. Work with Regulatory Affairs Strategist, CRO and Clinical Operations to ensure the Trial Master File (TMF) and Veeva RIM is kept current and complete for Regulatory Affairs-related documents. Monitor Regulatory Affairs training compliance via LMS. Oversee the timely and accurate update of Regulatory Affairs SOPs by working with SOP owners. Ensure Regulatory Affairs points of contact for each study kept current with the 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 slide decks summarizing compliance performance and trends. Support the investigation, tracking and timely closure of Quality Events, including root cause analysis and development of corrective and preventive actions (CAPAs), as required. Collaborate closely with SMEs to support deviation assessment and authorship, ensuring timely and high‑quality documentation. Coordinate with GPS and Regulatory Affairs SMEs to conduct impact assessments for new and evolving regulations and support development of implementation plans. Collaborate with Quality Assurance and cross‑functional stakeholders to support health authority inspections across GPS and Regulatory Affairs, ensuring the RA function remains in a continuous state of inspection readiness. Author, review, and maintain procedures and standards relevant to Regulatory Affairs Partner with Corporate Training to maintain training matrices and ensure training requirements are current and aligned with procedural and regulatory expectations.

Education:

Bachelor's degree in related discipline and a minimum of 5-7 years of related experience; or, Master's degree in related discipline and a minimum of 3-5 years of related experience; or, Equivalent combination of education and experience.

Experience:

5 years of regulatory affairs experience in the pharmaceutical industry Experience with audits and inspections preferred, but not required

Knowledge, Skills and Abilities:

Develops and manages plans, establishes timelines, sets standards for performance. Proactively balances commitments and overcomes challenges to complete multiple activities and achieve results. Takes pride in delivering high quality work. Applies extensive knowledge of the regulatory framework, industry drivers and practices to develop innovative approaches and manage complex work. Demonstrates clear and effective verbal and written communication. Provides timely and appropriate information updates. Speaks clearly and confidently in one to one situations and effectively presents information to cross-functional groups of colleagues. Strong interpersonal skills and ability to accommodate differing views to influence an agreed upon resolution. Applies knowledge of organizational goals and objectives and demonstrates advanced skill and insight in gathering, analyzing and applying key information to solve problems. Provides regulatory expertise to cross-functional teams. Understands longer term consequences of decisions and actions. Capable of proactively assessing workload, trends, tasks and priorities for area of responsibility. Plans and executes multiple activities. Considers alternative methods and contingency plans to avoid potential issues.

Work Environment/Physical Demands:

Our office is a modern, open-plan space that foster collaborations and creativity. Teams work closely together, sharing ideas and solutions in a supportive atmosphere. We provide all necessary equipment, including dual monitors and ergonomic chairs, to ensure a comfortable workspace. Travel requirements can be listed by stating up to certain % of time traveling.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job. We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance.