Regulatory Affairs Consultant - Regulatory Generalist

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. We are seeking a highly organized and collaborative Regulatory Affairs Generalist to support a strategic pharmaceutical partnership and its associated development and commercial programs. This role is dedicated to providing end‑to‑end regulatory affairs support for partnered assets, working closely with internal teams and external alliance stakeholders to ensure regulatory excellence across clinical, submission, and post‑approval activities. Serving as a key regulatory interface within the partnership, the Regulatory Affairs Generalist plays a critical role in regulatory planning, documentation management, submission execution, and ongoing compliance with global regulatory requirements. The ideal candidate thrives in a dynamic, cross‑company environment, effectively balances multiple priorities, and brings strong communication, problem‑solving, and collaboration skills to support successful partnership outcomes. The Regulatory Affairs Generalist provides comprehensive support across clinical, submission, and post approval regulatory activities for assigned pharmaceutical products and development programs. This role works cross functionally to ensure operational excellence in regulatory planning, documentation management, submission execution, and compliance with global regulatory requirements. The ideal candidate thrives in a dynamic environment, is highly organized, and demonstrates strong communication and problem-solving skills. Key Responsibilities 1. Regulatory Archiving & Documentation Management Maintain U.S. regulatory archive logs, including: Recording new submissions. Archiving regulatory authority correspondence. Upload and manage correspondence from global partners for assigned programs. Ensure proper indexing, version control, and compliance using Regulatory Information Management (RIM) systems, electronic document management systems (EDMS), or other applicable archiving tools. Ensure records are complete, audit ready, and aligned with internal SOPs and regulatory expectations. 2. Clinical Regulatory Support Maintain and update trackers for Form FDA 1572 waiver requests and other clinical regulatory documentation. Conduct GLP reviews of study documentation on behalf of Regulatory Affairs to support IND level compliance. Author 1572 waiver requests and support routine regulatory submissions for clinical investigators. Attend cross functional clinical trial team meetings as the Regulatory Affairs representative, providing regulatory interpretation, updates, and risk assessments. 3. Regulatory Submission Preparation Draft administrative components of regulatory submissions, including: FDA forms Cover letters Submission metadata and other supporting documents Build and organize electronic submission structures using RIM systems or industry standard submission planning tools. Manage internal workflows and approval processes to ensure timely completion of submission components. Coordinate submission package delivery through established publishing workflows and oversee communication with submission/publishing teams. 4. Global Regulatory Team (GRT) & Cross Functional Collaboration Prepare presentation materials and slide decks for Global Regulatory Team (GRT) meetings, governance discussions, and alliance meetings. Serve as the Regulatory Affairs representative in partner or alliance meetings for assigned products, providing updates and tracking action items. Support ongoing cross functional program meetings as needed, ensuring regulatory deliverables and timelines remain on track. 5. Authoring & Reviewing Regulatory Submissions Contribute to the drafting, review, and preparation of regulatory submissions across development phases, including: FDA meeting requests Briefing documents Applications for special regulatory designations (e.g., Fast Track, Orphan Drug Designation) IND submissions, amendments, and associated documentation Ensure content is scientifically sound, consistent, clear, and aligned with regulatory standards and internal templates. 6. Post Approval Regulatory Maintenance Prepare, review, and submit periodic post marketing regulatory reports for assigned products, including: PADERs (Periodic Adverse Drug Experience Reports) NDA Annual Reports DSURs (Development Safety Update Reports) PBRERs (Periodic Benefit Risk Evaluation Reports) Maintain tracking and compliance with global post approval commitments, submission deadlines, and regulatory requirements. Support lifecycle management activities to ensure continued product compliance. Skills: Project management knowledge Client-focused approach to work Results orientation Teamwork and collaboration skills Consulting skills Excellent interpersonal and intercultural communication skills, both written and verbal Critical thinking and problem-solving skills Proficiency in local language and extensive working knowledge of the English language Knowledge and Experience: 5 years of related regulatory affairs experience in an industry-related environment Education: Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred. Other: Due to the client’s location, candidates located in the Eastern or Central time zones of the US or Canada are preferred. The ability to travel up to 20% may be required. #LI-LB1 EEO Disclaimer Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Parexel is a leading global clinical research organization (CRO) providing insights-driven Clinical and Consulting solutions to the world’s life sciences industry. Leveraging deep local knowledge and a global breadth of clinical, regulatory and therapeutic expertise, our professionals worldwide work in partnership with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind — broadening access and making clinical research a care option for anyone, anywhere. Our proven track record spans 40 years and drives us forward, advancing clinical research in healthcare’s most complex areas while harnessing innovation to drive efficiencies across every phase of the clinical development process. Our insights-driven approach, proven delivery and trusted execution are accelerating the delivery of life-changing treatments to patients — With Heart.™