Senior Regulatory Affairs Associate - Regulatory Compliance

Senior Regulatory Affairs Associate - Regulatory Compliance

Overview

As part of Parexel Consulting, you will play a vital role in helping biopharmaceutical and medical device companies navigate the complex and ever-changing regulatory landscape. Drawing on your scientific, technical, and regulatory expertise, you will work closely with clients to develop and implement regulatory strategies that bring their products to market faster and keep them there.

We value collaboration, innovation, and continuous learning. As a member of our team, you will partner with a diverse group of clients, and be exposed to various product types and therapeutic areas. You will also develop your skills through challenging assignments and mentorship from experienced regulatory professionals. Plus, you will enjoy the flexibility of working remotely while still being part of a supportive and dynamic team.

Success Profile

Do you have these soft skills and interpersonal traits to succeed at Parexel?

• Communicator
• Detail-oriented
• Problem-solver
• Relationship-builder
• Results-driven
• Strategic

About This Role

About Parexel

Parexel is a leading global clinical development partner delivering insights-driven clinical and consulting solutions to the life sciences industry. With 22,000+ employees worldwide, we partner with biopharmaceutical companies and research sites to design and deliver patient-focused clinical trials that broaden access and make research a care option for anyone, anywhere.

We work with focus, agility, and shared purpose – moving with urgency to address patient needs and accelerate the delivery of new therapies. We embrace bold thinking, adapt quickly to change, and continually raise the bar for the speed and quality of clinical research. We are expanding our team and seeking talented individuals to help drive industry-leading innovation, With Heart®.

About the Role

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.

Key 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

• Candidate Profile

You'll thrive in this role if you bring:

• 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)

• Required Qualifications

• 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

• Preferred Qualifications

• 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

• Benefits and Compensation

• 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

• For a complete list of benefits, please visit www.parexel.com/us-benefits.

• We offer competitive salaries and a comprehensive benefits package to eligible employees, which includes paid time off, a 401(k) match, life insurance, health insurance, and additional benefit offerings in accordance with the terms of our applicable plans.

• Some roles may also be eligible for additional incentives, bonuses, or other compensation programs. Our Talent Acquisition team will provide details on applicable bonus plans or incentive structures for eligible positions.

• If this job doesn't sound like the next step in your career, but perhaps you know of someone who'd be a perfect fit, send them the link to apply!

• We believe in flexibility, growth, and creating space for people to do their best work. Join us and be part of a team where your contributions help shape the future of clinical research.

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• EEO Disclaimer

• Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the United States includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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