Manager, Regulatory Compliance

This is a fully remote position, open to applicants in United States.

📋 Description

• Deliver essential support for regulatory compliance efforts from planning to execution.

• Assist in the maintenance of Standard Operating Procedures (SOP) and ensure GxP compliance.

• Facilitate GRA inspection and audit readiness, as well as management activities.

• Manage compliance and tracking related to regulatory impact assessments.

• Oversee GRA-related controlled document revision cycles and any ad-hoc revisions.

• Collaborate with the GSOP office to organize Key Operating Meetings (KOMs), manage timelines, follow up, and provide assistance to stakeholders.

• Maintain knowledge and accessibility to GSOP systems, including Veeva Vault and Monday.com.

• Keep the GRA SOP revision tracker updated and engage in quarterly GSOP meetings.

• Serve as the GRA representative during DEAL reviews.

• Lead activities to prepare for inspections, managing inspection calendars, functional presentations, KOM scheduling, notifications, document requests, audit report reviews, and tracking CAPAs and deviations.

• Collaborate with Regulatory Intelligence and Pharmacovigilance for annual RRS updates.

• Engage in the review and qualification of PV dashboard curated inbox notifications.

• Design and implement newsletters and compliance communication strategies.

• Coordinate monthly updates for regulatory milestone reports in conjunction with Regulatory Strategy.

• Organize and facilitate GRA meetings and departmental events.

• Maintain the GRA Collaboration Portal, contact lists, Outlook distribution lists, and organizational charts.

• Analyze compliance metrics and trends, provide recommendations for KPIs, and generate monthly reports while driving corrective actions.

• Prepare and maintain compliance work instructions as well as onboarding and offboarding materials.

• Support cross-functional meetings with project reports, presentations, agendas, minutes, outcome tracking, and follow-up on deliverables.

• Ensure that plans and activities adhere to timelines and escalate any challenges or deviations.

• Create, administer, and summarize surveys as required.

⛳️ Requirements

• Bachelor’s degree in life sciences, scientific, or engineering disciplines.

• A minimum of 4 years of experience in general regulatory affairs.

• Familiarity with the drug development process.

• At least 3 years of experience in audits and inspections.

• Previous experience in the pharmaceutical and/or healthcare sectors is preferred.

• Experience with new prescription drug/biologic applications, including IND and/or NDA/BLA, is preferred.

• Excellent verbal and written communication skills.

• Solid understanding of the drug development process, relevant laws, regulations, and guidelines, including those from the FDA and ICH.

• Outstanding organizational skills and a willingness to learn and develop.

• Proficient in managing and communicating issues, scopes, progress, and risks throughout the project lifecycle.

• Ability to prioritize tasks, multitask, solve problems, and thrive in a fast-paced environment.

• Capability to build working relationships with cross-functional teams.

• Strong proficiency in Microsoft Word, Excel, PowerPoint, and Outlook.

• Familiar with electronic document management systems (EDMS).

• Ability to propose innovative solutions to problems.

🏝️ Benefits

• Opportunity for incentives.

• Comprehensive coverage for medical, dental, vision, and prescription drugs.

• Basic life insurance provided by the company.

• Accidental death and dismemberment insurance.

• Short-term and long-term disability insurance.

• Tuition reimbursement available.

• Assistance with student loans.

• Generous 401(k) matching program.

• Flexible time off policies.

• Paid holidays.

• Paid leave programs.

• Additional company-provided benefits.