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Sr. Director, Regulatory Affairs

Job Title: Sr. Director, Regulatory Affairs
Date: April, 2024
Department: R&D – Regulatory
Reports to: Sr. VP, Regulatory Affairs

Classification: Exempt
Type of position: Full Time

Opthea is a clinical stage biopharmaceutical company committed to developing innovative therapies to help improve visual function in patients suffering with retinal diseases. Our first in class novel therapeutic called OPT-302, is a VEGF-C/D ‘trap’, to be used in combination with existing standard of care anti-VEGF-A therapies to improve vision in patients, many of whom respond sub-optimally or become refractory to existing treatments.

Millions of people around the world suffer from impaired vision and blindness from retinal diseases. Opthea is committed to improving vision in patients suffering from retinal eye diseases starting with wet AMD.

OPT-302 is a first in class novel VEGF-C/D ‘trap’ and has the potential to address the significant unmet medical need of wet age-related macular degeneration (AMD) patients, many of whom respond sub-optimally or become refractory to existing therapies for these debilitating diseases. We are advancing the clinical development of OPT-302 in wet AMD. OPT–302 delivered compelling Phase 2b superiority results and is currently recruiting patients into two Phase 3 pivotal trials. Based on our Phase 2b results and the unmet medical need for the treatment of wet AMD, the FDA has granted Opthea Fast Track designation for OPT-302.

Our mission is to improve vision leading to a better quality of life.

Position Overview:

The Sr. Director, Regulator Affairs will report into Sr.VP, Regulatory Affairs and focus on regulatory landscapes to ensure compliance and expedite product approvals. Sr. Director, RA will work on developing and implementing regulatory strategies to support product development, registration, and lifecycle management.

Position Responsibilities:

  • Bring innovative regulatory approaches, deeply rooted in science, to lead the team in discussions with Health Authorities globally to find the best development strategies for novel therapies in the areas where no other precedents exist
  • Be responsible for the development, implementation, and maintenance of robust regulatory strategies in different phases of development
  • Drive the execution of regulatory plan for select projects through close collaboration with multiple functional areas
  • Build and update contingency plans for issues that affect registration scenarios and continued lifecycle management of the product, and ensures strategy is in alignment with CMC, commercial strategies, and the Target Product Profile
  • Lead the preparation of regulatory dossiers for submissions to US FDA.
  • Lead the preparation and participate in meetings with Health Authorities (HAs) in US and OUS markets.
  • Lead the working group to create or update the CCDS and contribute to the development of labels as appropriate.
  • Provides regulatory input to clinical development programs, risk/benefit assessments, medical affairs programs and for the target label
  • Ensure compliance with internal and external policies and legislation
  • Support or lead Due Diligence activities as appropriate

Position Qualifications:

Education and Certification Requirements

  • Minimum of a Bachelor’s degree in a scientific field (required)
  • Advanced degree (MS, PhD, MD or Pharm D) (preferred), RAC a plus

Qualifications & Skills

  • A minimum of 12 years’ experience in pharmaceutical industry
  • At least 8 years of Regulatory Affairs experience required with focus on the NA region and FDA, ophthalmology drug development experience preferred
  • Experience establishing productive working relationships with Health Authorities and gaining a deep understanding of how they view certain drug development issues.
  • Outstanding communication and presentation skills, with the ability to effectively engage with internal and external stakeholders.
  • Strategic mindset with a track record of driving financial performance and value creation.
  • Strong leadership abilities with a focus on team development, mentorship, and talent management.
  • Demonstrated ability to build and maintain positive relationships with management, peers, co-workers, vendors, business partners, etc.
  • Candidates with well-established networks and active relationships with clinicians in the ophthalmology community will be preferred.
  • Strong verbal and written communication skills; including ability to clearly present information and respond to questions from project teams and vendors.
  • Strong attention to detail and organization with the ability to manage large volumes of information and competing priorities.
  • Must possess strong critical thinking, analytical and data presentation skills..
  • Ability to energetically embrace responsibilities and demonstrate ability to achieve goals.
  • Strong initiative with ability to function well as part of a cross-functional team.
  • Experience in a start-up environment highly preferred.
  • Moderate travel will be required – ability to travel 30-50%.

Compensation

An attractive compensation package will be offered to the successful candidate. It will include a competitive base salary, incentive bonus, and equity. A benefits package customary to the position will also be provided including 401k match, medical, dental, vision insurances and other benefits.

Opthea is an equal opportunity employer.

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