Director, Regulatory Affairs

Go Fractional; Northern (KY); Híbrido; USD 413 000 - 482 000; Tempo integral

Resumo da oferta

Lexitas Pharma Services, Inc. is seeking a Fractional Director of Regulatory Affairs to lead and execute regulatory strategy across CDER, CBER and CDRH for ophthalmic products.

This role requires strategic leadership and hands-on execution across the FDA landscape, with proven success in agency interactions and global regulatory coordination. The position emphasizes developing regulatory strategy while driving tactical execution, supporting products from early-stage through commercialization,

Qualificações

• Extensive ophthalmology regulatory experience.
• Proven FDA submission and agency interaction expertise.
• Ability to develop regulatory strategy while driving tactical execution.
• Experience supporting product development from early-stage through commercialization.

Responsabilidades

• Provide strategic leadership across FDA regulatory landscape.
• Lead regulatory submissions and agency interactions.
• Drive cross-functional collaboration to advance development programs.

Conhecimentos

Ophthalmology regulatory

FDA submissions

Regulatory strategy

Cross-functional leadership

Regulatory execution

Descrição da oferta de emprego

We’re looking for purpose-driven, passionate individuals to join our team. From clinical to commercial to supporting functions, Lexitans believe in the common mission: to be the best ophthalmic product development organization to partner with.

Lexitas is searching for a Fractional Director of Regulatory affairs tobring both strategic leadership and hands-on execution experience across the FDA regulatory landscape, with deep expertise in ophthalmic products. This individual should have demonstrated success navigating regulatory pathways and interactions across all three FDA medical product centers:

• CDER (Center for Drug Evaluation and Research)
• CBER (Center for Biologics Evaluation and Research)
• CDRH (Center for Devices and Radiological Health)

Key qualifications include:

• Extensive ophthalmology regulatory experience
• Proven FDA submission and agency interaction expertise
• Ability to develop regulatory strategy while driving tactical execution
• Experience supporting product development from early-stage through commercialization
• Strong cross-functional collaboration and leadership skills

Highly desirable ("nice-to-have") qualifications:

• International regulatory affairs experience supporting product development and commercialization outside the U.S.
• Familiarity with regulatory frameworks and health authority interactions in Europe/UK, Latin America, Japan, Australia, and broader APAC markets, including China
• Experience developing global regulatory strategies and coordinating submissions across multiple jurisdictions

Physical Requirements

Position requires: ordinary ambulatory skills and physical coordination sufficient to move aboutconference or meeting locations as required; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

Disclaimer:

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. Lexitas Pharma Services, Inc., at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

The pay range for this role is:

300 - 350 USD per hour (Remote (United States))