Senior Regulatory Affairs Manager

Panther Life Sciences • New York, NY

18h

About The Position

About Panther: Panther is unlocking the tremendous biological powers of our skin to deliver a wide range of shelf-stable treatments. Panther’s precisely engineered microarray patches (MAPs) are focused on: i) Skin Health, treating coloration, wrinkles, scars, wounds, etc.; and ii) Therapeutics, treating ailments along the immunological spectrum, including infectious diseases, cancer, allergies and autoimmune diseases. Panther’s MAPs are designed to deliver superior efficacy and high levels of usage/adherence, and enable automated data integration across its ecosystem of consumers, providers and treatment developers. Panther’s AI enabled platform provides personalized customer care and accelerated treatment discovery. Via advanced GMP manufacturing, direct-to-consumer distribution and consumer self-application, Panther’s MAPs are affordable, simultaneously enabling universal access and commercial success. Panther is led by accomplished tech, biotech and health professionals The Opportunity Panther Life Sciences is seeking a senior regulatory affairs manager to shape the future of its regulatory strategy across an ambitious portfolio spanning cosmetics, medical devices, and therapeutics. This is a high-impact leadership role at the intersection of science, strategy, and innovation, managing one of Panther’s most critical areas of investment while architecting the regulatory roadmap that will bring transformative, shelf-stable, patient-centric treatments to market. This role is central to Panther’s success.The direction will architect the regulatory frameworks required to bring transformative, shelf-stable, patient-centric treatments to global markets, spanning cosmetics, medical devices, and therapeutics. As a key member of the leadership team, the director will drive U.S. FDA and international submissions, every stage of product development from concept to global launch. This individual brings a rare combination of ambition, humility, precision, and deep collaboration, paired with a passion for next-generation medical products and improving the patient experience. The right leader will help unlock Panther’s full potential. Some travel may be required approximately 10%.

Requirements

• 8–12 years of medical device regulatory experience, with at least 3 years in a lead role at a company developing a novel, non-predicate device
• Direct experience navigating novel device classification pathways with FDA CDRH (De Novo, PMA), including preparation of classification arguments and special controls frameworks
• Working knowledge of 21 CFR 878 and familiarity with CDRH reviewers in the aesthetic/dermatology device space
• Proven ability to independently own Pre-Submission (Q-Sub) meetings with FDA
• Practical experience operating under ISO 22716, ISO 13485, and ISO 9001

Nice To Haves

• Demonstrated experience navigating combination product risk
• Prior TGA / Australian regulatory experience
• Familiarity with aesthetic device submissions
• Background at an early-stage or Series A/B device company where regulatory strategy is built from the ground up
• Understanding of how novel device classification intersects with IP strategy
• Working knowledge of the MoCRA framework

Responsibilities

• Regulatory Strategy (U.S. & Global) Define and execute regulatory pathways for devices, therapeutics, cosmetics, and platform submissions.
• Lead FDA filings (including RFD and IND pathways) and guide parallel global filings.
• Ensure tight integration between regulatory strategy, R&D, clinical, and commercial teams.
• Strategic Company Initiatives Lead medical device approval for Panther’s device(s), including at least one parallel global agency.
• Lead clinical trial preparation and documentation Support quality initiatives in accordance with ISO 9001

Benefits

• Equity in the form of Stock Options
• Robust Health Insurance includes Medical, Dental, Vision
• Life, AD&D, and Short-Term Disability Insurance
• In-person company events
• Fully-stock kitchen
• In-office lunch twice a week
• Working with a world-class team in technology and healthcare on the most innovative solutions
• Paid time off and Paid Company Holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed