HimalayasHimalayas logo
Harrow HealthHH

Regulatory Affairs Manager, CMC & Clinical Development

Harrow, Inc. is a leading eyecare pharmaceutical company focused on the discovery, development, and commercialization of innovative ophthalmic products for the U.S. market. They are dedicated to making medications more accessible and affordable, partnering with eyecare professionals to provide a diverse portfolio of high-quality products for various eye conditions and surgeries.

Harrow Health

Employee count: 201-500

United States only

Stay safe on Himalayas

Never send money to companies. Jobs on Himalayas will never require payment from applicants.

Harrow is seeking a Regulatory Affairs Manager to develop and execute regulatory strategies across the product lifecycle, including early-stage development, IND submissions, clinical trial support, NDA filings, and post-approval CMC activities.

Requirements

  • BS/BA Degree in a Scientific Discipline, an advanced degree preferred
  • 6+ years of pharmaceutical Regulatory Affairs experience
  • Direct experience authoring or leading IND submissions
  • Regulatory support for clinical trial programs (Phase 1–3)
  • CMC regulatory strategy and lifecycle management experience
  • Demonstrated experience interacting with the FDA on clinical development programs

Benefits

  • Generous Paid Time Off
  • 401k Matching

About the job

Apply before

Posted on

Job type

Full Time

Experience level

Location requirements

Hiring timezones

United States +/- 0 hours

About Harrow Health

Learn more about Harrow Health and their company culture.

View company profile

Since our founding in December 2011, we at Harrow have been driven by a singular mission: to make essential medications more accessible and affordable for everyone. It all began from a place of recognizing a critical need, and though we started with no products or customers, our dedication has allowed us to blossom into a recognized leader within the ophthalmic pharmaceuticals sector and a name that eyecare professionals across the nation trust. This incredible journey is a testament to the hard work and commitment of every member of the Harrow Family, the unwavering support of our valued shareholders, and our deeply ingrained '100% no-excuses' philosophy that guides us in serving our customers and, most importantly, the patients who rely on our products.

Our story is one of resilience, innovation, and a relentless pursuit of excellence. After navigating some initial hurdles, we proudly began generating revenue in April 2014 under our ImprimisRx brand. Our very first offering, a compounded intraocular injectable steroid and antibiotic, was initially produced in a modest 2,500-square-foot facility in Randolph, New Jersey. The positive response from ophthalmologists was immediate and overwhelming. As demand for our products grew, we realized we were charting new territory; there was no existing roadmap for building a national ophthalmic pharmaceutical compounding business. Undeterred, we embraced collaboration, ingenuity, and sheer hard work to develop the sophisticated systems and processes necessary to support our expanding brand and serve an ever-increasing number of eyecare professionals. Today, our state-of-the-art facility in Ledgewood, New Jersey, equipped with advanced automation and robotics, stands as a symbol of our commitment to the highest standards of pharmaceutical manufacturing. We are licensed in all 50 states and registered with and inspected by the FDA and DEA, reflecting our dedication to quality and compliance. Over the past decade, we've partnered closely with U.S. eyecare professionals to cultivate a diverse portfolio of high-quality products. These products are utilized in a wide array of ophthalmic surgeries and are prescribed to manage chronic and acute conditions such as dry eye disease, glaucoma, allergies, and infections. We also provide specialized products for in-office procedures performed by retinal specialists, including intravitreal injections. By always prioritizing the clinical value we deliver to both providers and their patients, we empower professionals to achieve better outcomes and preserve the precious gift of sight. Our vision for the future is ambitious but clear: we aim to be a top-tier North American ophthalmic pharmaceutical company, continuously empowering eyecare professionals, enhancing patient outcomes, ensuring our medicines are both accessible and affordable, and delivering sustained value to our shareholders.

Claim this profileHarrow Health logoHH

Harrow Health

View company profile

Similar remote jobs

Here are other jobs you might want to apply for.

View all remote jobs

Remote companies like Harrow Health

Find your next opportunity by exploring profiles of companies that are similar to Harrow Health. Compare culture, benefits, and job openings on Himalayas.

View all companies

Find your dream job

Sign up now and join over 100,000 remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan