Senior Manager, Regulatory Affairs

The Senior Manager, Regulatory Affairs will play a key role in devising and supporting the strategic and operational execution of global regulatory activities for Oculis’ pipeline of innovative small and large molecule therapeutics in ophthalmology and neuro-ophthalmology. The ideal candidate brings a blend of strategic thinking, strong regulatory knowledge, exceptional communication, and medical/regulatory/technical writing skills. The role requires learning agility, operational flexibility, problem-solving, cross-functional collaboration, and the ability to manage complex regulatory submissions and interactions with minimal supervision. Reports To: Head of Regulatory Affairs Function: Research & Development Level: Senior Manager Location: Boston Position Summary The Senior Manager, Regulatory Affairs will lead the development and execution of global regulatory strategies for Oculis’s pipeline of innovative small and large molecule therapeutics in ophthalmology and neuro-ophthalmology. This role requires advanced regulatory expertise, strategic thinking, and the ability to manage complex submissions and health authority interactions with minimal supervision. The Senior Manager will serve as a key regulatory resource, influencing program decisions and ensuring compliance with global standards. Strategic Regulatory Leadership Contribute to the development and refinement of global regulatory strategies aligned with Oculis’ development and commercial objectives. Gather and analyze global regulatory intelligence and regulatory precedents to inform submission planning, product positioning, and appropriate regulatory strategy and decision making. Support the development of global labeling and contribute to cross-functional Labeling Teams and Submission Teams. Anticipate potential regulatory risks and proactively identify mitigation strategies. Operational Excellence (Global and Regional) Prepare and lead regulatory submissions including INDs, CTAs, Health Authority Meeting Briefing Packages, Orphan Drug Designations, iPSP/PIP submissions, NDA/MAA components, responses to Agency questions, and other regulatory deliverables. Author high-quality regulatory documents for US, EU, and other regulatory agencies, ensuring alignment with ICH, FDA, EMA, and other global guidelines. Support planning and execution of regulatory interactions and Health Authority meetings. Ensure compliance with global regulatory requirements, SOPs, and industry best practices. Areas of Focus Medical, Technical, Regulatory Writing: Serve as the primary author for key regulatory documents, including clinical protocols, investigator brochures, health authority briefing documents, and global CTD Modules 1–5. Regulatory Intelligence: Monitor regulatory developments, interpret guidance documents, collect relevant regulatory precedents, and provide strategic input to internal stakeholders. Labeling Strategy: Support development, review, and negotiation of labeling documents with EMA, FDA, and national authorities. Regulatory Risk Assessment: Identify and communicate regulatory risks; propose strategic/risk‑mitigation solutions. Cross-Functional Collaboration Act as regulatory liaison and partner with Clinical Development, CMC, Nonclinical, Quality, Pharmacovigilance, and Commercial teams. Provide regulatory input into clinical/nonclinical study design, CMC documentation, and product lifecycle planning. Collaborate with quality and compliance teams to ensure GxP adherence. Support pharmacovigilance and safety reporting activities as required. Regulatory Expertise: Understanding of global regulatory frameworks, guidelines, regulations (FDA, EMA, ICH, etc.), and product development processes. Strategic Thinking: Ability to balance short‑and‑long‑term regulatory objectives and align with broader company strategy. Very good clinical knowledge. Communication Skills: Effective written and verbal communication for regulatory writing and agency interactions. Medical/Regulatory/Technical Writing: Demonstrated experience as the primary author of complex regulatory documents with the ability to translate scientific data into clear, concise, and persuasive submissions. Project Management: Ability to prioritize and manage multiple projects in a dynamic, fast‑paced environment. Collaboration: Skilled at working in cross‑functional and multicultural teams, fostering cooperation and alignment. Learning Agility: Demonstrates openness to feedback and willingness to rapidly adapt to new information and feedback. Qualifications Advanced degree in Life Sciences (PhD, PharmD, MSc strongly preferred). 5–7+ years of experience in Regulatory Affairs within biotech or pharmaceutical industry. Proven track record of leading global submissions and health authority meetings. Strong knowledge of FDA, EMA, and ICH guidelines. Ability to thrive in a fast‑paced, evolving environment with a hands‑on, problem‑solving approach. Oculis Sàrl is an equal‑opportunity employer and does not discriminate on the basis of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age, disability, genetic information, or any other characteristic protected by applicable laws. We are committed to creating a diverse and inclusive workplace where all employees feel valued, respected, and supported. All qualified applicants will receive consideration for employment without regard to any of the aforementioned factors. We encourage individuals from all backgrounds to apply. #J-18808-Ljbffr Oculis Inc.