Regulatory Affairs Manager

Regulatory Affairs Manager - Permanent - PennsylvaniaJoin the team advancing first-in-class therapies and play a pivotal role in shaping the regulatory pathway for novel treatments in the rare disease space. Proclinical is seeking a Regulatory Affairs Manager to contribute to the advancement of novel drug and biologic development programs in the rare disease space. The position offers significant ownership and visibility across innovative programs, with exposure to both CMC and broader clinical regulatory activities. Primary Responsibilities:The successful candidate will focus on developing CMC regulatory strategies, authoring high-quality submission content, and collaborating with cross-functional teams to support regulatory submissions from early development through critical milestones. Skills & Requirements:Bachelor's degree in a scientific discipline (advanced degree preferred).Hands-on experience in Regulatory Affairs within biotechnology, pharmaceutical, consulting, or academic environments.Expertise in authoring and reviewing CMC content for IND submissions, including CTD Modules 2 and 3.Strong understanding of drug development, CMC requirements, and regulatory submission processes.Experience working with manufacturing teams and external CMOs.Ability to navigate evolving or incomplete information effectively.Strong technical writing, review, and communication skills.Collaborative mindset with the ability to work independently and within cross-functional teams. Preferred Experience: Experience with first-in-class or early-stage development programs.Exposure to biologics, advanced therapies, or complex pharmaceutical products.Consulting experience or work with academic investigators.Familiarity with both CMC and clinical regulatory activities. The Regulatory Affairs Manager's responsibilities will be:Develop and execute CMC regulatory strategies for novel drug and biologic programs.Author, review, and refine regulatory documentation, including CTD Module 2 Quality Overall Summaries and Module 3 CMC sections.Prepare and support INDs and other global regulatory submissions.Provide strategic guidance on CMC development approaches, regulatory expectations, and product control strategies.Collaborate with manufacturing, quality, analytical development, pharmaceutical development, and clinical teams.Partner with external CMOs and development partners to ensure regulatory readiness.Translate complex regulatory requirements into actionable guidance for technical stakeholders.Contribute to regulatory risk assessments, mitigation strategies, and agency meeting preparations.Support clinical regulatory activities and contribute across multiple regulatory disciplines as needed. If you are having difficulty in applying or if you have any questions, please contact Peter Duvall at p.duvall@proclinical.com. If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page. Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy. By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy