Senior Regulatory Affairs Associate – Regulatory Compliance

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

📋 Description

• Serve as the SOP Coordinator for Global Regulatory Affairs, overseeing controlled document revision cycles as well as ad-hoc updates.

• Organize Kick-Off Meetings, oversee timelines, support document updates, and manage the GRA SOP revision tracker.

• Maintain expertise and access to GSOP systems, including Veeva Vault and Monday.com.

• Aid in inspection readiness through managing the inspection calendar, preparing presentations, sending notifications, handling document requests, and compiling audit reports, CAPAs, and Deviations.

• Collaborate with the Regulatory Intelligence and Pharmacovigilance teams for the annual updates of the Regulatory Requirements Summary.

• Review and qualify notifications from the Pharmacovigilance dashboard curated inbox.

• Create and disseminate newsletters and compliance communications.

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

• Organize and lead GRA staff, steering group, and departmental meetings.

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

• Prepare KPI reports, encompassing training metrics, and publish findings on the GRA Collaboration Portal.

• Develop and uphold compliance work instructions, SOP revisions, milestone reviews, and onboarding/offboarding materials.

• Provide comprehensive meeting support, including project reports, presentation materials, agendas, minutes, and follow-up on deliverables.

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

• Maintain compliance performance metrics and generate status reports for management and project teams.

• Engage in continuous improvement initiatives.

• Design, administer, and analyze surveys.

⛳️ Requirements

• Bachelor's degree in a life sciences, scientific, or engineering discipline.

• A minimum of 3 years of general regulatory affairs experience along with knowledge of the drug development process within the pharmaceutical sector.

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

• Excellent oral and written communication skills.

• Strong understanding of the drug development process, including relevant laws, regulations, and guidelines such as FDA, ICH, and other regulatory requirements.

• Experience within regulatory affairs, healthcare, or other regulated environments.

• Familiarity with document management systems and regulatory compliance tools.

• Proficient experience with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).

• Ability to prioritize effectively and thrive in a fast-paced environment while managing multiple tasks and solving problems.

• Preferred: Previous experience with new prescription drug/biologic applications (IND and/or NDA/BLA).

• Preferred: Knowledge of electronic document management systems (EDMS).

🏝️ Benefits

• Health, Vision & Dental Insurance.

• Tuition Reimbursement.

• Vacation/Holiday/Sick Time.

• Flexible Spending & Health Savings Accounts.

• Work/Life Balance.

• 401(k) with Company match.

• Pet Insurance.

• Paid time off.

• Life insurance.

• Additional benefit offerings in accordance with applicable plans.

• Some positions may qualify for extra incentives, bonuses, or other compensation programs.