Senior Regulatory Affairs Associate - Regulatory Compliance

Overview

Senior Regulatory Affairs Associate - Regulatory Compliance supporting regulatory compliance activities from planning to execution, in alignment with the Global Regulatory Compliance Lead, across the Global Regulatory Affairs function.

What you'll do

• Function as SOP Coordinator for GRA-related controlled document revision cycles and ad-hoc revisions, including scheduling Kick-Off Meetings with the Global SOP office, managing timelines, and maintaining the GRA SOP revision tracker.
• Maintain knowledge of and access to GSOP systems such as Veeva Vault and Monday.com, participate in quarterly GSOP engagement meetings, and serve as GRA representative for DEAL reviews.
• Support inspection readiness, including managing the inspection calendar, developing functional area slide presentations, scheduling KOMs, communicating audit and inspection notifications, supporting pre-document requests, reviewing final audit reports, and tracking CAPAs and Deviations.
• Collaborate with Regulatory Intelligence and Pharmacovigilance teams to identify and confirm annual Regulatory Requirements Summary (RRS) updates.
• Participate in review and qualification of Pharmacovigilance dashboard curated inbox notifications.
• Develop and support distribution of newsletters and compliance communications on regulatory updates and requirements.
• Coordinate and facilitate monthly updates for regulatory milestone reports in partnership with Regulatory Strategy.
• Support coordination and facilitation of GRA meetings, including full staff meetings, Steering Group Regulatory Team (SGRT) meetings, and departmental face-to-face meetings.
• Maintain the GRA Collaboration Portal, identify outdated materials, and manage quarterly updates with key stakeholders.
• Maintain GRA contact lists, Outlook GRA distribution lists, and departmental organizational charts.
• Prepare monthly key performance indicator reports, such as training metrics, and post results on the GRA Collaboration Portal.
• Prepare and maintain compliance functional area work instructions, such as SOP revisions, GRA milestone reviews, and onboarding/offboarding materials.
• Provide meeting support for cross-functional GRA meetings, including project reports, presentation materials, agendas, and minutes, and follow through on all deliverables.
• Ensure plans and activities are implemented in accordance with established timelines and escalate challenges or deviations in a timely manner.
• Maintain regulatory compliance performance metrics and generate status reports for management and project teams.
• Participate in continuous improvement initiatives to enhance regulatory compliance processes and efficiency.
• Create, administer, and summarize surveys to gather feedback and support decision-making.

What you'll need

• Bachelor's degree in a life sciences, scientific, or engineering field.
• 3+ years of general regulatory affairs experience and knowledge of the drug development process in the pharmaceutical industry.
• 3 years of audit and inspection exposure and/or experience.
• Strong oral and written communication skills.
• Solid working knowledge and understanding of the drug development process, laws, regulations, and guidelines, including FDA, ICH, and other regulatory requirements.
• Strengths in regulatory compliance, process management, and cross-functional collaboration.
• Experience working in regulatory affairs, healthcare, or a regulated environment.
• Ability to collaborate across teams and communicate clearly with diverse stakeholders.
• A patient-focused mindset and strong attention to detail.
• Comfort working with document management systems and regulatory compliance tools.
• Results-oriented, entrepreneurial, and self-motivated with excellent organizational skills.
• Ability to prioritize and work well in a fast-paced environment while multi-tasking and problem-solving.
• Strong demonstrated experience with Microsoft Office programs (Word, Excel, PowerPoint, Outlook).

Nice to have

• Prior experience with new prescription drug/biologic applications (IND and/or NDA/BLA).
• Familiarity with electronic document management systems (EDMS).
• Ability to consider and offer innovative solutions to problem-solving.

Details

• Remote position in the United States.
• Benefits include health, vision and dental insurance, tuition reimbursement, paid vacation/holiday/sick time, flexible spending and health savings accounts, 401(k) with company match, and pet insurance.