Director, Regulatory Strategy

Welcome to the Tarsanet Internal Career Center!; Irvine (CA); Hybrid; USD 188,000 - 264,000; Full time

Benefits offered by this job

Onsite gym

Pool

Snacks & drinks

Catered meals

Hybrid work

Job summary

Tarsus Pharmaceuticals in Irvine, CA, seeks a Director of Regulatory Strategy to lead global regulatory activities for assigned products, with emphasis on US FDA programs, pre- and post-approval. You will act as regulatory lead on project teams, requiring 10+ years of regulatory affairs experience and an MS/PhD/PharmD.

Hybrid work and travel up to 10% are expected. The role reports to the VP, Regulatory Affairs and offers bonus, stock options, and comprehensive benefits.

Qualifications

• Requires at least 10 years of regulatory affairs experience with advanced degree.
• Strong written and verbal communication, leadership, and project management skills.
• Deep understanding of US FDA and international regulatory guidance and drug development.

Responsibilities

• Provide regulatory leadership on project teams with focus on development and clinical regulatory affairs.
• Oversee/prep regulatory submissions (IND/CTA/NDA/MAA) and ensure quality/timeliness.
• Collaborate with cross-functional teams to plan, prioritize, and execute submissions.
• Develop strategic regulatory plans and interpret regulatory feedback and guidelines.

Skills

Regulatory leadership

Regulatory affairs

Project leadership

US FDA knowledge

Education

MS/PhD/PharmD

Job description

About the Role

The Director, Regulatory Strategy will provide leadership on global regulatory activities for the assigned products, with a focus on US regulatory affairs both pre- and post-approval. The individual will function as the regulatory lead for their assigned projects. Experience in development and clinical regulatory activities and providing regulatory leadership on the project teams in this area is required. The candidate will also directly provide or oversee pre- and post-approval submissions activities. The candidate should have a good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices. A high attention to detail, ability to coordinate and prioritize assigned activities according to project goals and strong interpersonal skills, both written and verbal, are desired. The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, PhD or PharmD).

Key responsibilities of the role:

• Provide regulatory leadership on the project teams, with a focus on development and clinical regulatory affairs, but with good knowledge of other areas of regulatory affairs.
• Work with project teams to resolve complex project issues utilizing regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements.
• Work in close collaboration with other functional leads to plan, prioritize, supervise and/or conduct project activities.
• Provide interpretation of regulatory authorities’ feedback, policies and guidelines.
• Develop regulatory strategic plans, either directly or in conjunction with project teams.
• Lead or oversee the preparation of regulatory submissions for assigned projects; responsible for quality and timeliness of IND/CTA/NDA/MAA and post-approval submissions.
• Work with cross-functional partners and contractors in the preparation, review, and completion of documents for regulatory submissions.
• Provide strategic leadership and development to other regulatory strategists to ensure innovative, robust, fit-for-phase regulatory strategies for from FIH to approval.
• Provide regulatory strategy leadership for business development and due diligence, including assessment of asset, risk identification and mitigation, precedent leverage, regulatory probability of success
• Establish best practices across Regulatory Affairs and other R&D functions to ensure consistent, high-quality execution
• Follow company policies and procedures for regulatory record keeping and lead development of new regulatory policies and procedures.
• Advance the organization’s goals by participating in and taking leadership roles in professional associations, industry, and trade groups as appropriate for assigned projects.

Factors for Success:

• The candidate must have at least 10 years of regulatory affairs experience and a higher degree (MS, Ph.D. or Pharm D.).
• Excellent verbal and written communication skills.
• Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills evidenced by past performance on drug development project teams.
• Ability to thrive in a fast-paced, entrepreneurial environment.
• Ability to function at a high level in a team setting or acting as an individual contributor.
• An excellent understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• A high attention to detail and ability to coordinate and prioritize assigned projects.
• Decision Making - Identifies, analyzes, and resolves issues or challenges effectively and efficiently. Demonstrates creativity, decisiveness, and the capacity to implement solutions in a structured and outcome-oriented manner. Navigates uncertainty when there’s not a blueprint for success. Owns their decisions and actions.
• Collaboration and Team Building - Builds strong relationships and networks. Is curious about and respectful of different points of view. Cultivates a safe space for discussion readily engaging in group dialogue and debate. Puts the team first.
• Outcome Driven - Clearly defines mutual expectations of self and others in a team setting. Adapts to changing business needs. Is determined and resourceful in finding solutions, even when faced with obstacles. Takes appropriate actions, including calculated risks, to ensure obligations are met.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with onsite gym, pool, snacks, drinks, and occasional catered meals. We provide a hybrid work environment; remote work may be considered.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our VP, Regulatory Affairs.
• Some travel may be required – up to 10%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $188,200 - $263,600 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit: https://eb.alliant.com/26tarsusbenefitssnapshot .

Will you now or in the future require Tarsus Pharmaceuticals, to commence ("sponsor") an immigration case to employ you (for example, H-1B or other employment-based immigration case)? This is sometimes called "sponsorship" for an employment-based visa status. * Select...

We may refuse to hire relatives of present employees if doing so could result in actual or potential problems in supervision, security, safety, morale, or if doing so could create conflicts of interest. Do you have any relatives working for Tarsus Pharmaceuticals? * Select...

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Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey.Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiringprocess or thereafter. Any information that you do provide will be recorded and maintained in aconfidential file.

As set forth in Welcome to the Tarsanet Internal Career Center!'s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection.As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measurethe effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categoriesis as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.