Senior Regulatory Affairs Associate - Regulatory Compliance

Parexel•Southport, NC

4d•Remote

About The Position

We are seeking a Senior Regulatory Affairs Associate - Regulatory Compliance to join our team in a remote capacity. As a Senior Regulatory Affairs Associate - Regulatory Compliance, you will provide critical support for regulatory compliance activities from planning to execution, working in alignment with the Global Regulatory Compliance Lead and collaborating closely with cross-functional teams throughout the organization. This position plays a key role in SOP maintenance, GxP compliance, inspection and audit readiness, and regulatory impact assessment tracking. You'll work with diverse teams, follow industry-standard processes, and contribute to regulatory excellence across the Global Regulatory Affairs function. You'll join a fast-paced, growth-oriented environment focused on making a meaningful impact through regulatory compliance excellence, operational efficiency, and cross-functional collaboration. With diverse teams and continuous learning opportunities, the Senior Regulatory Affairs Associate - Regulatory Compliance can explore career paths and expand skills across regulatory affairs and clinical research.

Requirements

Bachelor's degree in 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
The 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 Haves

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

Responsibilities

Function as SOP Coordinator supporting all Global Regulatory Affairs (GRA)-related controlled document revision cycles and ad-hoc revisions, including working with the Global SOP office to schedule Kick-Off Meetings (KOMs), managing timelines, supporting GRA key stakeholders with document revisions, maintaining knowledge and access to GSOP systems (such as Veeva Vault and Monday.com), maintaining the GRA SOP revision tracker, participating in quarterly GSOP engagement meetings, and serving as GRA representative for DEAL reviews
Support inspection readiness activities including management of the inspection calendar, supporting development of functional area slide presentations, scheduling KOMs, communicating audit and inspection notifications to the team, 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 to keep stakeholders informed of 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 such as full staff meetings, Steering Group Regulatory Team (SGRT) meetings, and departmental face-to-face meetings
Maintain updates to the GRA Collaboration Portal, identify outdated materials, and manage quarterly updates with key stakeholders to ensure accuracy of posted information
Maintain updates to GRA contact lists, Outlook GRA distribution lists, and departmental organizational charts
Prepare monthly reports for key performance indicators 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 meetings within GRA, including development of project reports, presentation materials, meeting agendas, and meeting minutes, and identify outcomes and follow through on all deliverables
Ensure plans and activities are implemented in accordance with established timelines and escalate any challenges or deviations for resolution 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 as needed to gather feedback and support decision-making