Regulatory Affairs Senior Consultant - Regulatory Lead

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. Are you a seasoned regulatory expert with a passion for guiding innovative pharmaceutical products through the complex landscape of clinical development? Parexel is seeking a dynamic and strategic Senior / Consultant - Regulatory Lead to join our team. In this pivotal role, you will lead regulatory submissions, ensure compliance with global regulations, and collaborate with multidisciplinary teams to bring groundbreaking therapies to market. If you thrive in a fast-paced environment and are eager to make a significant impact on global health, we want to hear from you! As a Regulatory Affairs Senior / Consultant - Regulatory Lead, you will be responsible for: Strategic and Operational Leadership: Focus on clinical regulatory filings Provide strategic and operational leadership on project teams Support ongoing clinical development activities Lead IND/CTA and BLA submissions for products in development and marketed products Regulatory Knowledge and Application: Integrate and apply knowledge of global regulations, with emphasis on US FDA regulations Ensure compliance with pharmaceutical drug development regulations across quality, preclinical, and clinical programs Monitor and interpret newly published FDA guidelines and international guidance documents Provide training on applicable requirements for scientific staff as needed Regulatory Strategy Development: Develop regulatory strategies for assigned programs in collaboration with senior management Analyze guidance and assess precedent information for similar indications Obtain approval for activities supporting development and marketing objectives within specified timelines Health Authority Communication: Communicate with FDA and other health authorities for assigned programs Manage regulatory activities associated with drug development programs Submission Management: Plan, prepare, and submit Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs) Manage IND amendments, annual reports, and other regulatory documents and correspondence Ensure completeness and accuracy of all regulatory submissions Multidisciplinary Team Collaboration: Participate in and provide regulatory guidance to multidisciplinary project teams Communicate regulatory goals and requirements to team members Guide teams on content, format, style, and architecture of regulatory applications Document Preparation and Review: Edit or manage the editing of scientific sections of regulatory applications Assist with writing, reviewing, and preparing regulatory documents Perform critical analyses of clinical, preclinical, and manufacturing data Develop independent interpretations and conclusions Review clinical protocols and study reports to identify deficiencies or missing information BLA-Specific Responsibilities: Provide guidance on Biologics Licensing Application (BLA) preparation Assist with scientific writing and review of BLAs Evaluate BLA conformance with regulatory requirements Qualifications: Bachelors or Advanced degree in a scientific discipline (Ph.D. or equivalent preferred) Minimum of 5+ years of experience in regulatory affairs in a similar capacity within the pharmaceutical or biotechnology industry Extensive knowledge of global pharmaceutical regulations, particularly US FDA regulations. Depth of previous experience will determine Consultant or Senior Consultant level Strong understanding of drug development processes and regulatory requirements with an emphasis on clinical module requirements Excellent analytical, writing, and communication skills Previous experience authoring Orphan Drug Designation Meeting packages Ability to work effectively in multidisciplinary teams Experience in managing regulatory submissions, preferably INDs and BLAs Previous experience successfully leading cross functional teams in a deadline focused regulatory environment Previous Biologics experience Due to the nature of the role and client and team interaction, candidates located in the EST are highly preferred. 10-15% travel may be required This position requires a detail-oriented individual with strong leadership skills, capable of managing complex regulatory processes and ensuring compliance with global pharmaceutical regulations. #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. Headquartered near Boston, Massachusetts and in Durham, North Carolina, Parexel has over 16,000 employees, with offices that support clients in over 100 countries around the world. We provide the most comprehensive drug development capabilities of any CRO worldwide. Our global regulatory expertise, Phase I-IV clinical research services, and advanced commercialization services all work together to move you through the development journey more smoothly and cost-effectively from beginning to end.