Senior Manager/Director, Regulatory Affairs (Generalist)

Senior Manager/Director, Regulatory Affairs (Generalist) Are you a regulatory affairs leader who thrives on variety, strategic thinking, and solving complex development challenges? G&L is an agile, science-driven regulatory consultancy headquartered in Madison, New Jersey, partnering with innovative biotech and pharmaceutical companies across all stages of product development. As we continue to grow, we are seeking an experienced Senior Manager or Director of Regulatory Affairs to join our expanding team. This is an opportunity for a regulatory professional who enjoys working across diverse programs, therapeutic areas, and modalities. You will lead and support multiple concurrent client engagements, partnering closely with both emerging biotech companies and established global organizations. We work on small molecules, biologics, and advanced therapies, giving you the chance to build broad experience while making a meaningful impact on client development strategies. No two projects are the same - this role is ideal for someone who enjoys balancing strategic leadership with hands-on execution. The Role As a senior member of G&L’s regulatory team, you may contribute across a range of activities, including: Regulatory Strategy & Development Provide strategic regulatory guidance to clients across early and late-stage development programs Advise cross-functional teams on development pathways, submission strategy, and health authority expectations Lead or contribute to the planning, preparation, and authoring of regulatory submissions (including INDs/CTAs, BLAs/NDAs/MAAs) and drive regulatory strategy and lifecycle management activities as a Global or US Regulatory Lead across development phases Program leadership and execution Lead regulatory workstreams across multiple client engagements Develop and drive project plans, timelines, and key deliverables Coordinate cross-functional contributors across G&L’s global team, authoring activities, publishing, and submission readiness Provide practical solutions to keep programs moving forward in fast-paced environments Health Authority interactions Support or lead communications or interactions with regulatory agencies, including the FDA Develop health authority engagement strategy and interaction plan Prepare teams for agency interactions, briefing materials, and responses to regulatory questions Lead the preparation of responses to health authority inquiries Act as a trusted advisor during review and milestone activities CMC Regulatory Support, including: Lead or contribute to the development and review of CMC regulatory documentation Support CMC strategy and submission planning for investigational and marketing applications Provide oversight of CMC content across complex development programs Requirements What we’re looking for: We recognize that the strongest candidates may not check every box. We’re looking for professionals who bring: Significant experience (approx. 7-10 years) in US regulatory affairs within biotech, pharma, or consulting Broad knowledge across regulatory strategy, submissions, and product development The ability to operate at both strategic and operational levels Strong communication, client leadership, and stakeholder management skills A collaborative mindset, intellectual curiosity, and a willingness to tackle new challenges At G&L, you’ll work alongside a global team of regulatory experts who are passionate about helping clients bring important therapies to patients. We value people who are practical, entrepreneurial, and willing to roll up their sleeves to find creative solutions. If you’re looking for a role where you can broaden your expertise, work on genuinely varied programs, and have the freedom to make an impact - we’d love to hear from you. G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process. #J-18808-Ljbffr