Regulatory Affairs Professionals Society
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Biotechnology, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Tarsus Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical company developing novel therapeutics for eye care and other specialties, starting with Demodex blepharitis. The Company was founded in 2017, currently has 30+ employees, and is growing rapidly. Tarsus just moved into new facilities to support its growth that includes new formulation and analytical development labs located on site in Irvine, CA.
Afflicting approximately 20 million Americans, blepharitis is a common ocular surface disease with no FDA-approved drug options. Tarsus’ lead product candidate, TP-03, is Phase 3-ready and works to eradicate mites by paralyzing their nervous systems. In addition to Demodex blepharitis, the Company is actively engaged in developing a pipeline for dermatological and infectious disease indications with significant market opportunities.
Tarsus has filled out a solid management team comprised of highly experienced leaders, created a robust pipeline, and have begun enrollment on their Phase 2b/3 program for Demodex blepharitis in 2020.
Tarsus Pharmaceutical raised $101 million in its initial public offering in October and the company’s common stock is trading on the Nasdaq Global Select Market under the symbol “TARS”. The capital raise will be used to complete Phase 2b/3 trials for TP-03 and fuel Phase 1 and 2 development of other clinical programs. Their Company management team is comprised of experienced leaders in pharma, seasoned board members, and a distinguished advisory board in ophthalmology.
Tarsus Pharmaceuticals is on a mission to discover and deliver breakthrough treatments to transform the lives of patients with common and poorly treated diseases, starting with the eye. Tarsus’s flagship product, TP-03, has the potential to be the first FDA-approved therapeutic and the standard of care for the treatment of Demodex blepharitis.
Demodex blepharitis is caused by infestation of Demodex mites, the most common ectoparasite found on humans. There are two species of Demodex-folliculorum and brevis-that live on the skin of the face and eyelids.
Pipeline Summary & Leadership Information
Tarsus is seeking a Vice President, Regulatory Affairs, to be based in Irvine, CA and report to the Chief Operating Officer. This position will lead the global regulatory submissions as well as preside over the company’s overall leadership to ensure development and execution of regulatory strategies and plans to enable efficient global development of products in the portfolio.
This senior executive will partner closely with the other R&D functions to guide and execute on the strategic direction of the development programs and assure they are designed to meet regulatory approval standards on a global basis, advancing the company’s portfolio towards product approval and subsequent commercial success.
The Vice President, Regulatory Affairs will be a strategic, dynamic, highly collaborative, and successful senior executive who will have significant experience and a successful track record with global regulatory leadership in both development-stage programs and marketed products. This person will utilize this experience to serve as a true R&D business partner, who, as part of the senior management team of Tarsus, will contribute to the growth of the company by providing their expertise toward driving programs to registration as well providing expert opinion and assessment of external assets of interest to Tarsus. Additionally, this executive, as the most senior regulatory voice at the company, will lead and build out the regulatory function and support other peer functions within R&D.
The VP, Regulatory Affairs will also advise internal development functions such as Clinical, Medical, Nonclinical and CMC regarding regulatory impact of development decisions. (S)he will work collaboratively with Quality Assurance to ensure quality systems and compliance are maintained. (S)he will support business development activities including assessing partnership/in-licensing/out-licensing opportunities, collaborate with strategic and government partners, and support government affairs/advocacy activities.
Cultural fit of the successful candidate to the company is an extremely important criterion for their success at Tarsus. Characteristics sought for a good cultural fit include strong curiosity, intelligence, ability to think strategically and independently, ability to negotiate with and influence key stakeholders and decision makers, a “hands on” approach and attention to detail, ability to build excellent working relationships internally and externally, and an entrepreneurial spirit.
The Vice President, Regulatory Affairs will lead, manage and coordinate global regulatory activities for the company’s entire portfolio in collaboration with the Research, Clinical Development and Commercial teams.
The successful candidate will play a key role in creating, developing and implementing a regulatory strategy for Tarsus’s pipeline projects and manage global regulatory submissions and ensure that pipeline programs are approved in a timely manner with optimal labeling. The VP, Regulatory Affairs will serve as the primary point of contact with the global regulatory agencies with responsibility for all regulatory agency submissions, action items and communications worldwide.
Specific responsibilities include:
Contribute to the creation of the overall product development strategy and manage the development, monitoring and delivery of regulatory project plans throughout the life cycle.
The successful candidate will have an Advanced degree in a scientific discipline (M.S. Ph.D., PharmD) preferred, with at least 15 years of relevant regulatory experience with development and approval of multiple products. Knowledge and experience in eye care development and regulations is preferred. S/he should have a track record of successful interaction with the regulatory agencies, as demonstrated by timely submissions and approvals of pharmaceutical/biotech compounds, ideally in niche indications within various disease states.
Specific professional experience and qualifications include:
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