VP, Regulatory Affairs
Eloxx Pharmaceuticals, Inc. is a clinical-stage Rare Disease biopharmaceutical company focused on restoring production of essential proteins depleted due to genetic mutations. Our library of novel drug candidates enable read-through of premature stop codons and have shown dose dependent improvements in restoring essential protein functions across multiple disease areas. Our lead investigational product candidate, ELX-02 has been granted Orphan Disease designation and is advancing to Phase 2 in Cystic Fibrosis and Cystinosis. Our recently announced Inherited retinal disease program and our partnership with the Foundation Fighting Blindness has created an opportunity to advance additional library compounds into clinical development. We anticipate continuing our rapid growth as the Company advances in clinical development, enters additional therapeutic areas and expands our pipeline.
Eloxx Pharmaceuticals (ELOX) is a Nasdaq listed biotechnology company headquartered in Boston MA with regional operations in New Jersey, Pennsylvania and Tel Aviv Israel.
As the leader of Regulatory Affairs, you will be responsible for building a high-performing Regulatory function and overseeing submission management activities, design and implementation of regulatory systems and tools, regulatory project management and compliance. In this role, you will be responsible for setting the long-term strategy and vision for the regulatory function, creating and executing regulatory strategies, and collaborating with Eloxx leadership to set goals, drive process efficiencies and overall operational effectiveness for global regulatory submissions.
Reporting to the Chief Operating Officer, the candidate will leverage broad knowledge and expertise to lead key cross-functional initiatives and global filings. The candidate will take a company-wide approach to problem solving and provide Eloxx colleagues with the information and innovative tools required to prepare successful and high-quality regulatory submissions, creating a seamless environment for all stakeholders.
- Lead the regulatory function and enable successful product development, approvals and life-cycle management.
- Establish the long-term strategy for the regulatory team, activities and planning in accordance with an established road-map and with an expectation to scale-up efficiently and rapidly.
- Provide strong cross-functional leadership for global filings, and to support the growth of the regulatory department.
- Build and maintain strong leadership capabilities at all levels within the regulatory team and support the professional development of regulatory team members.
- Ensure the successful on time delivery of high-quality submissions to global regulatory health authorities in alignment with both Eloxx and health authority standards.
- Oversee the development and implementation of innovative systems, tools and streamlined processes to create and maintain high-quality regulatory submissions and manage a state-of-the-art regulatory intelligence and knowledge management approach.
- Responsible for continuous improvement of systems and processes, including internal training, for the regulatory department and cross functional teams
- Ensure inspection readiness efforts for regulatory activities and files
- Manage regulatory budgets and vendors
- Maintain current expertise in regulatory trends and operations
- Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science
- Ability to critically evaluate opportunities and assess risks
- Ability to prioritize responsibilities and meet deadlines
- Ability and interest in “rolling up their sleeves” to perform “hands-on” regulatory activities
- Demonstrated proficiencies in leading successful health meetings and interactions
- Independently motivated, excel at driving execution, detail oriented
- Excellent analytical and problem-solving skills
- Excellent organizational skills to multi-task in a fast-paced environment with changing priorities
- Demonstrated ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment
- Excellent verbal and written communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, and senior management and external agencies
- Excellent cross-functional leadership and project management skills.
- Ability to work at the strategic and tactical level and comfortable shifting back and forth
- Enthusiastic positive upbeat “can do” attitude to the office; doesn’t take themselves too seriously, has a sense of humor
- Minimum 10-15 years in pharmaceutical / biopharmaceutical industry (ideally both mid-size and large companies).
- Extensive regulatory management experience and in developing innovative regulatory solutions.
- Track record of success in gaining approval of original NDAs, MAAs and / or BLAs (experience with orphan or rare diseases is highly desired)
- Experience managing post-approval changes
- Success in fostering effective team spirit.
- Experience in leading multidisciplinary teams
- Relevant knowledge in CMC, clinical and nonclinical science
- Knowledge expert regarding global regulatory submission standards, and publishing best practices.
- Experience with process design and improvement and with developing systems from the ground up.
- Bachelor’s degree required, PhD, MD or Pharm D degree preferred.
In addition to offering competitive salaries, Eloxx Pharmaceuticals offers a full benefit package including healthcare, dental, vision, short and long-term disability, life insurance, 401(k) retirement saving plan, and paid holiday and vacation days.
Eloxx Pharmaceuticals is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.