Committed to the preservation of vision.
Help bring the first ophthalmic formulation of bevacizumab to people living with wet AMD.

Regulatory Lead

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ABOUT OUTLOOK THERAPEUTICS

Outlook Therapeutics (Nasdaq: OTLK) is a commercial-stage biopharmaceutical company redefining the standard of care in retinal disease. In the United States, our lead product has received FDA approval, making it the first and only FDA-approved ophthalmic formulation of its kind for the treatment of wet AMD, and we are preparing for US commercial launch. Our lead product is also the first ophthalmic formulation of its kind to receive Marketing Authorization from the European Commission and the UK MHRA for the treatment of wet age-related macular degeneration (wet AMD), and has launched across Germany, Austria, and the UK.  Driven by the stories of the patients we serve, we are united with the vision-care community around a single goal: a future where everyone with retinal disease can envision a brighter world.

THE OPPORTUNITY

Reports To – EVP, Medical, Clinical & Regulatory Affairs
Level – Director / Senior Director
Location – Remote (US-based), East Coast preferred, with global scope
Employment Type – Full-time
Direct Reports – No initially; contractors and vendors oversight

This is a rare ground-floor moment at a company hitting its commercial inflection point. As a lean, fast-moving organization, we offer scope and ownership that larger companies can’t: your work is visible, your decisions matter, and you’ll help build the function rather than simply maintain it. You’ll partner directly with senior leadership and see a clear line between what you do and patients gaining access to a new treatment option.

This is the regulatory seat for a product live in Europe and US. You’ll own filings across every market we operate in — hands on the submissions, not one step removed from them — and you’ll build the vendor and contractor network that scales the function as we expand.

WHAT YOU’LL DO

Global Filings & Submissions

  • Own end-to-end preparation, compilation, and submission of regulatory filings across US, EU, UK, and expansion markets.
  • Manage BLA and MAA maintenance, variations, renewals, and lifecycle submissions post-approval.
  • Prepare and submit CTAs, INDs, briefing documents, and health authority responses on committed timelines.
  • Evaluate changes to regulatory documents and determine correct filing categories and submission pathways.
  • Maintain the global submission calendar and hold cross-functional contributors to deliverable dates.

Health Authority Engagement

  • Serve as primary liaison with FDA, EMA, MHRA, and national competent authorities across launch markets.
  • Lead preparation for health authority meetings, including strategy, briefing materials, and cross-functional rehearsal.
  • Drive resolution of regulatory questions, information requests, and filing issues to closure.
  • Track evolving FDA, EMA, and ICH guidance and translate implications into practical action for the business.

Regulatory Strategy

  • Formulate submission strategy and tactics for assigned programs across biologics and combination product requirements.
  • Advise on device and delivery system regulatory pathways where the product presents as a combination product.
  • Identify, mitigate, and communicate regulatory risk at the program level to senior leadership.
  • Represent Regulatory Affairs on cross-functional project teams and serve as regulatory lead for assigned programs.
  • Own advertising and promotional (adpromo) material reviews, ensuring compliance with health authority requirements across markets.

Cross-Functional & Vendor Management

  • Partner with Clinical, CMC, Quality, and Manufacturing to ensure submission-ready documentation.
  • Direct CROs, regulatory consultants, and local in-country representatives across markets.
  • Build and manage the contractor and vendor network as filing volume grows.
  • Establish and maintain regulatory operations processes, systems, and document standards.

WHAT YOU’LL BRING

Required

  • Bachelor’s degree in a life science; advanced degree preferred.
  • 8+ years in regulatory affairs within biotechnology or biopharmaceuticals, with progressive ownership of filings.
  • Demonstrated expertise preparing and submitting registration documents — BLAs, MAAs, INDs, CTAs.
  • Direct experience with global filings, whether depth in multiple countries at a single-product company or breadth across programs at a larger organization.
  • Direct experience with biologics, including regulatory strategy across the product lifecycle.
  • Direct experience with combination products, including device and delivery system regulatory requirements.
  • Proven health authority interaction experience, including FDA and at least one EU or UK authority.
  • Strong CMC literacy and the ability to work fluently with technical and manufacturing colleagues.
  • Hands-on experience with manufacturing and release specifications and related documentation.
  • Experience leading or performing advertising and promotional (adpromo) material reviews.
  • Willingness to work across US and European time zones; East Coast strongly preferred.

Preferred

  • Ophthalmology or retina experience.
  • Experience supporting a first commercial launch or entry into new international markets.
  • Experience managing regulatory consultants, CROs, or in-country representatives.
  • Background spanning both small-company and large-company regulatory environments.
  • Experience mentoring junior regulatory staff.

WHAT WE OFFER

  • Competitive base salary, annual performance bonus, and equity — so you share in the value you help create
  • Comprehensive health coverage: medical, dental, and vision
  • 401(k) with company match
  • Generous paid time off and company holidays
  • A high-trust, low-bureaucracy culture with direct access to leadership and real room to grow
  • Mission-driven work that helps preserve sight for patients who are counting on it

COMPENSATION

In keeping with our commitment to pay transparency, the good-faith base salary range for this role is $195,000-$255,000 with an annual target bonus of 15-25% (depending on candidate). This role is also eligible for a meaningful equity grant, reflecting the opportunity to build lasting value at a company at a commercial inflection point. Final compensation reflects experience, skills, and location.

OUR COMMITMENT

Outlook Therapeutics is an equal opportunity employer. We are committed to building an inclusive environment where every team member can do their best work, and we consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.

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