This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Associate Regulatory Affairs Quality, Standards & Training Director (Global Patient Safety) based in United States.
This role provides compliance oversight across Global Patient Safety and Regulatory Affairs, with a strong emphasis on Regulatory Affairs activities.
The position monitors regulatory compliance indicators, inspection-readiness standards, and operational performance across clinical programs.
It drives consistency by strengthening processes, identifying risks, and supporting continuous improvement initiatives.
The role works closely with Clinical Operations, Clinical Development, Quality Assurance, and regulatory subject matter experts.
It also supports regulatory inspections, quality event management, procedural standards, training, and regulatory change assessments.
The position offers an opportunity to influence quality and compliance practices across a complex, cross-functional pharmaceutical environment.
Accountabilities:
- Monitor regulatory compliance activities, including SmPC updates, Reference Safety Information trackers, health authority submissions, partner Investigator Brochures, Requests for Information, and aggregate reporting requirements.
- Ensure Regulatory Affairs documentation remains accurate, current, and complete within the Trial Master File and relevant regulatory information management systems.
- Monitor Regulatory Affairs training compliance and partner with Corporate Training to maintain accurate training matrices and requirements.
- Oversee timely updates to Regulatory Affairs SOPs, procedures, standards, and study-specific regulatory points of contact.
- Monitor and analyze key compliance metrics, identify trends and risks, and contribute to leadership dashboards and presentations.
- Support quality event investigations, including deviation assessments, root cause analysis, corrective and preventive actions, and timely closure of identified issues.
- Collaborate with subject matter experts to assess the impact of new and evolving regulations and support implementation plans.
- Partner with Quality Assurance and cross-functional teams to support health authority inspections and maintain continuous inspection readiness.
- Provide support to Regulatory Affairs strategy activities and development programs as needed.
- Identify and deliver quality-related training for Regulatory Affairs team members and support consistent application of regulatory procedures and standards.
- Coordinate across Regulatory Affairs, Global Patient Safety, Clinical Operations, Clinical Development, Quality Assurance, CROs, and other stakeholders to strengthen compliance and operational consistency.
- Perform additional responsibilities as assigned and comply with applicable policies and standards.
Requirements
- Bachelor’s degree in a related discipline with at least 11 years of relevant experience, or a Master’s degree with at least 9 years of relevant experience, or an equivalent combination of education and experience.
- 7–10 years of Regulatory Affairs experience within the pharmaceutical industry.
- Experience supporting audits and regulatory inspections is preferred.
- Strong knowledge of regulatory frameworks, pharmaceutical industry practices, and regulatory compliance expectations.
- Ability to develop and manage plans, establish timelines, define performance standards, and successfully manage multiple priorities.
- Strong analytical and problem-solving skills, with the ability to assess trends, risks, operational challenges, and longer-term consequences of decisions.
- Excellent written and verbal communication skills, including the ability to present complex information clearly to cross-functional stakeholders.
- Strong interpersonal and influencing skills, with the ability to accommodate differing perspectives and facilitate effective resolutions.
- Demonstrated ability to provide regulatory expertise to cross-functional teams and translate requirements into practical actions.
- Proactive approach to workload management, prioritization, contingency planning, and issue prevention.
- High attention to quality, accuracy, compliance, and timely execution.
- Ability to work effectively across functions and manage complex activities in a collaborative environment.
- Approximately 10% travel is required.
Benefits
- Annual base salary range of $163,000–$231,000, with the final offer adjusted based on geographic market, qualifications, experience, skills, and internal equity.
- 401(k) plan with company contributions.
- Medical, dental, and vision coverage.
- Life and disability insurance.
- Flexible spending accounts.
- Eligibility for a discretionary annual bonus program.
- Opportunity to purchase company stock and receive long-term incentives.
- 15 accrued vacation days during the first year.
- 17 paid holidays, including a company-wide winter shutdown in December.
- Up to 10 sick days annually.
- Remote work environment with equipment provided to support a comfortable and productive workspace.
- Collaborative working environment focused on cross-functional problem-solving and professional contribution.
How Jobgether works:
We use an AI-powered matching process to ensure your application is reviewed quickly, objectively, and fairly against the role's core requirements. Our system identifies the top-fitting candidates, and this shortlist is then shared directly with the hiring company. The final decision and next steps (interviews, assessments) are managed by their internal team.
We appreciate your interest and wish you the best!
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