NOTE: This position can be based in Irvine, CA or remote.
Reporting into the Chief Operating Officer, Vice President, Regulatory Affairs, 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:
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. The person 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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