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Regulatory

Vice President, Regulatory Affairs


NOTE: This position can be based in Irvine, CA or remote. 

Position Summary

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.

Key responsibilities

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:

  • Provide strategic direction to Regulatory Affairs department; lead Regulatory Affairs group, including hiring, mentoring and leading staff.
  • Guide and/or lead regulatory agency interactions, including communications and meetings.
  • Provide regulatory leadership and support to project/program teams and Senior Management for all aspects of the development program (nonclinical, clinical, quality (CMC) and labeling).
  • Effectively communicate requirements and compliance obligations under laws, regulations, and guidance in the US and around the world.
  • Direct and negotiate submissions (IND, CTA, NDA, MAA etc..) and approvals with regulatory authorities.
  • Strategize, lead, write and/or supervise the development of and submission of documents/dossiers to regulatory agencies to achieve development goals; ensure on-time, high-quality and regulatory–compliant submissions.
  • Provide support to regulatory reviews for due diligence initiatives, including opportunity and risk assessment.
  • 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.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

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:

  • Experience supporting both early and late phase development, including development and filing of associated regulatory submissions.
  • Experience in a start-up environment with a balance of risk taking and advancing products efficiently.
  • Experience managing and collaborating with outside partners/vendors.
  • Ability to collaborate effectively with internal and external key stakeholders.
  • Ability to review, understand and explain the regulations and guidance documents to guide project teams.
  • Proven success in communicating to and negotiating with FDA and global health authorities and managing clinical trial applications in several geographies around the world (for example US, Europe, Latin America, Asia).
  • Ability to drive meetings with various stakeholders: (i) senior management, (ii) regulatory agencies (iii) investors, (iv) expert advisors v) collaborators and vi) project teams.
  • Ability to comprehend and operate at high levels to address general issues and dig in deep to evaluate and address specific grass root issues
  • Passion, self-starter, outcomes-oriented and innovative thinker.
  • Outstanding written, oral, organizational, and interpersonal skills are required for this highly collaborative role.
  • Strong understanding of the drug development process.
  • Stature, experience, technical credibility, strong relationship management and interpersonal skills to quickly gain confidence both with internal stakeholders (CMC, preclinical, statistics, business development, legal, etc.) and externally among regulatory agencies. An individual who can influence strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make important decisions and shape outcomes.
  • Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with physicians, scientists, managers, peers and staff.
  • An individual who demonstrates humility, good judgment and strong analytical skills and adjusts quickly to changes.
  • Excellent organizational and project management skills and ability to think strategically.
  • Outstanding presentation, written and oral communication skills required. A clear communicator who can influence effectively both internally and externally.
  • A person of the highest integrity.
  • Ability to comprehend and operate at high levels to address general issues and dig in deep to evaluate and address specific grass root issues
  • Passion, self-starter, outcomes-oriented and innovative thinker.

EDUCATION

  • Advanced degree in a scientific discipline (M.S. Ph.D., PharmD) preferred, chemistry, biology or related sciences. An undergraduate degree is required.

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At Tarsus Pharmaceuticals, we value bringing together individuals from diverse backgrounds to drive better results for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Equal Employment Opportunity is the law, and you can find more information here. If you are an applicant and would like to request an accommodation, please email careers@tarsusrx.com.

Regulatory

Vice President, Regulatory Affairs


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