Regulatory Affairs Lead - Manager/Senior Manager/ Ophthalmology

Regulatory Affairs Lead - Manager/Senior Manager/ Ophthalmology

Location: Remote

Type: Full-time

Compensation: $165,000

Position Summary

Our biotech client is seeking a hands-on Regulatory Affairs professional to support the development of its ophthalmology programs in a small, fast-paced biotechnology environment. This role requires an individual who is equally comfortable developing and proposing regulatory strategies and executing the detailed work required to implement approved strategies.

Reporting to the Chief Medical Officer, the Regulatory Affairs Lead will work closely with R&D leadership and Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, Medical Affairs, and external regulatory consultants to develop regulatory recommendations and translate R&D leadership-approved regulatory strategies into executable plans and submissions. Regulatory recommendations will be developed in the context of the overall product development plan and corporate objectives.

The successful candidate will have broad regulatory experience and a demonstrated ability to work across multiple areas of Regulatory Affairs without relying on the specialized infrastructure typical of a large pharmaceutical company. This individual will be expected to roll up their sleeves and take ownership of regulatory deliverables from planning through submission, and independently drive approved regulatory activities and deliverables to completion.

Key Responsibilities

• Develop and propose global regulatory strategies and recommendations supporting clinical development, registration, and lifecycle planning for ophthalmology programs. Work with R&D leadership and cross-functional teams to refine these recommendations and execute regulatory strategies following R&D leadership approval.
• Translate approved regulatory strategy into detailed regulatory plans, timelines, health authority interactions, and submission activities, ensuring continued alignment with the clinical development plan and corporate objectives
• Take hands-on ownership of regulatory submissions, including planning, authoring, coordinating, reviewing, and driving documents through finalization and submission.
• Prepare and manage US regulatory submissions and interactions, including INDs, IND amendments, annual reports, safety-related submissions, briefing packages, requests for designations, responses to information requests, and regulatory correspondence
• Develop recommendations for the objectives, content, and regulatory approach for health authority interactions and, following alignment with R&D leadership, prepare and coordinate meeting requests and briefing packages, including Pre-IND, Type B, Type C, Type D, End-of-Phase 2, and other FDA interactions
• Prepare and support expedited and special designation requests, including Orphan Drug, Fast Track, and Breakthrough Therapy Designations, as applicable and consistent with the approved development strategy
• Support global clinical trial applications and development activities, with particular initial emphasis on the EU and UK, including CTAs, substantial modifications/amendments, responses to health authority questions, and maintenance of ongoing clinical trial authorizations
• Support development of global registration submissions, including BLAs and MAAs, as programs advance toward registration
• Coordinate regulatory activities with external consultants/contractors as appropriate, CROs, regulatory vendors, and submission/publishing resources while retaining internal ownership of regulatory deliverables, timelines, and execution
• Serve as a day-to-day regulatory partner to Clinical Development, Clinical Operations, CMC, Nonclinical, Quality, Pharmacovigilance, Technology, and other functions, providing regulatory analysis and recommendations and escalating significant strategic decisions to R&D leadership for alignment and approval
• Review protocols, investigator brochures, clinical documents, CMC and nonclinical documentation, safety documents, and other development materials for regulatory consistency and compliance with responsibility for generation of final formatted documents using company approved templates
• Maintain regulatory correspondence, submission histories, health authority commitments, regulatory trackers, agency questions and responses, and other regulatory records necessary to support the development program
• Monitor evolving FDA, EMA, MHRA, ICH, and other relevant regulatory requirements, assess their potential impact on development programs, and recommend appropriate actions to R&D leadership.
• Identify and escalate regulatory risks to R&D Leadership, develop practical options and recommendations, and support implementation of the approved approach
• Develop, maintain, and/or improve Regulatory Affairs processes, templates, working practices, and SOPs that are fit for purpose and scalable as the organization grows
• Support regulatory due diligence, partnering activities, and other business-development activities as requested
• Perform both strategic and operational Regulatory Affairs activities as needed in a lean organization; no task should be considered too detailed or too operational when required to move a program forward

All the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description.

Qualifications

• Bachelor's degree in life sciences, pharmacy, regulatory affairs, or a related scientific discipline; advanced scientific or healthcare degree preferred
• Typically 10-15+ years of progressively responsible Regulatory Affairs experience, with demonstrated depth and breadth of hands-on regulatory experience commensurate with a seasoned Manager/Senior Manager-level role
• Demonstrated experience working in a small or mid-sized biotechnology/pharmaceutical company, or equivalent experience operating with significant individual ownership and limited regulatory infrastructure
• Demonstrated hands-on experience preparing and managing regulatory submissions rather than solely providing strategic oversight or managing work performed by others
• Experience supporting clinical-stage drug or biologic development, including IND maintenance and FDA interactions
• Experience with several of the following required: FDA Pre-IND meetings, Type B/C/D meetings, End-of-Phase 2 meetings, IND amendments and annual reports, Orphan Drug Designation, Fast Track Designation, Breakthrough Therapy Designation, and registration planning.
• Practical experience supporting EU and/or UK clinical development and regulatory submissions strongly preferred. Experience with EMA, EU Clinical Trials Regulation/CTIS, MHRA, PIP activities, or other ex-US regulatory processes is an advantage
• Experience coordinating simultaneous or sequential regulatory activities across multiple regions
• Experience with biologics development strongly preferred
• Ophthalmology experience, including anterior segment, ocular surface, glaucoma, or related areas, is strongly preferred
• Strong knowledge of FDA regulations, ICH guidelines, and applicable global regulatory requirements.
• Excellent scientific and regulatory writing skills, with demonstrated ability to synthesize complex clinical, nonclinical, and CMC information into clear regulatory documents. xhyhwjd
• Ability to work closely with a scientific-medical writer when avaiable
• Strong organizational and project-management skills, including the ability to independently manage multiple regulatory deliverables, deadlines, consultants, and cross-functional contributors.
• Comfortable working in an entrepreneurial, highly collaborative environment with limited hierarchy, potential for changing priorities, and a high degree of personal accountability
• Demonstrated ability to identify what needs to be done, take ownership, and drive activities to completion without requiring extensive infrastructure or administrative support
• RAC certification is a plus but is not required