--- title: 'Manager I, Regulatory Affairs Operations at Tarsus Pharmaceuticals' canonical: 'https://feeny.ai/job/manager-i-regulatory-affairs-operations-tarsus-pharmaceuticals-irvine-california-9gh5pkrvps74' type: 'job' last_seen: '2026-09-08' --- # Manager I, Regulatory Affairs Operations at Tarsus Pharmaceuticals - **Company:** Tarsus Pharmaceuticals - **Location:** Irvine California, United States - **Posted:** 2026-07-31 - **Last confirmed live:** 2026-09-08 - **Apply:** https://tarsusrx.com/careers/apply/?gh_jid=6130385004 ## Job description ## About the Role The Manager I, Regulatory Affairs Operations will report to the Director, Regulatory Affairs Operations, and will primarily assist in managing Electronic Document Management System (Veeva Vault RIM) and regulatory submissions activities. Let’s talk about some of the key responsibilities of the role: - Create and Maintain Content Plans within Veeva Vault RIM, understanding of eCTD Hierarchy/Modules and content planning. - Assist with planning, managing, archiving of submissions/regulatory authority correspondence, Ad & Promo submissions, dossier lifecycle management. Maintain compliance to regulatory requirements for annual reporting, etc. - Support RA submissions team/s with project management activities, tasks and tracking. - Assist with coordination and communication of regulatory submissions with external Publishing vendors. - Ability to work with firm deadlines and adapt quickly to changing requirements and priorities. - Assist in Reg Ops team management and help to develop fully functional regulatory operations team, including processes and systems. - Excellent organization, written/verbal communication and attention to detail. - EDMS & Submission Technology: Proficiency in electronic submission tools and software, such as eCTD and regulatory information management systems (proficiency in Veeva RIMS required). In addition, proficiency working with eCTD templates (e.g., eCTD StartingPoint® Templates, etc.). Preferred technology: Veeva Vault RIM, Content Planning, eCTD Viewers, DXC (ISI) Toolbox. - Project Management Technology: Experience and proficiency with project management tools and software such as Microsoft Word, Project, Excel, etc. - Maintenance of individual training records and completion of all designated required training. Factors for Success: - Bachelor’s degree in science or health-related discipline or equivalent experience. - Minimum of 5+ years of Regulatory Affairs Operations Experience, with a focus on publishing and/or submissions management, records management. - In-depth understanding of regulatory requirements and guidelines including FDA regulations, EMA guidelines and ICH standards. Keywords: eCTD, NDA, IND, EU CTA, MAA, EU CTR, NDS - Under the guidance of the Director, knowledgeable resource for regulatory advice in developing submission content plans, with hands-on responsibility for regulatory document management. - Experience working with Veeva Regulatory Information Management System Vault is required; administrator experience/management of Veeva RIMS is a requirement. - Experience in interpreting regulations, guidelines, and policy statements, including comprehensive knowledge of applicable regulations with demonstrated expertise relevant to RA operational activities. - Demonstrated ability to contribute to a continuous learning and process improvement. - Strong analytical skills, good attention to detail. - Ability to work concurrently on projects, each with specific instructions that may differ from project to project. Ability to work independently as needed with minimal supervision. - 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 an 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 Director, Regulatory Affairs Operations. - Some travel may be required – up to 20%. At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $97,500 - $136,500 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. #LI-Hybrid #LI-Remote Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. ## About Tarsus Pharmaceuticals ## Company Overview - **One-liner**: A biopharmaceutical company creating novel therapies to treat the root cause of diseases, starting with eye care and expanding into dermatology and infectious disease prevention. - **Entity Type**: Public (NASDAQ: TARS) - **Headquarters**: Not publicly available in provided sources (inferred to be Irvine, CA, but not confirmed) - **Founded**: 2016 - **Founders**: Bobak Azamian, MD, PhD and Michael Ackermann ## Core Business - **Primary industry**: Biopharmaceuticals (eye care, dermatology, infectious disease prevention) - **Target customers**: Patients with high unmet medical needs; prescribing eye care professionals, dermatologists, and other healthcare providers (B2B/B2C hybrid) - **Mission or purpose**: To revolutionize treatment for patients with unmet needs by pursuing the root cause of disease, not just symptoms. ## Products & Services - **[XDEMVY® (lotilaner ophthalmic solution) 0.25%]**: The first and only FDA-approved treatment for Demodex blepharitis, an eyelid disease affecting approximately 25 million Americans. (Product, prescription medicine) - **[TP-03 (lotilaner ophthalmic solution)]**: Investigational treatment for Meibomian Gland Disease (MGD), currently in Phase 2a clinical trial. (Pipeline candidate) - **[TP-04]**: Investigational treatment for Rosacea (ocular rosacea), currently in Phase 2a clinical trial. (Pipeline candidate) - **[TP-05]**: Oral tablet for the prevention of Lyme disease, currently in Phase 2a clinical trial. (Pipeline candidate) ## Market Standing - **Valuation/Market Cap**: Not disclosed in provided sources (public company, stock price available via LSEG with 15-minute delay) - **Key Metric**: Annual Revenue – Not disclosed in provided sources (public company, quarterly earnings reported; Q1 2026 results mentioned but figures not included) - **Notable Investors/Partners**: Initial backing from Versant Ventures and Third Rock Ventures (per founder background); global partnerships mentioned but not specified. - **Growth Signals**: FDA approval of first product (XDEMVY); advancing three pipeline candidates into Phase 2a trials; partnership with John Cena to raise awareness of Demodex blepharitis; public listing enabling further financing. ## Competitive Advantages - **First-mover category**: XDEMVY is the only FDA-approved treatment for Demodex blepharitis, creating a new category in eye care. - **Root-cause approach**: Focus on treating the underlying cause of disease rather than symptoms, potentially offering more durable solutions. - **Expanding pipeline**: Leveraging the same platform (lotilaner) to address multiple large, underserved conditions (MGD, rosacea, Lyme disease prevention). - **Strong leadership and culture**: Experienced management team with deep biotech expertise; culture of teamwork, empowerment, and commitment. ## Strategic Focus - **Current priorities**: Commercialize XDEMVY and expand its reach; advance Phase 2a trials for TP-03, TP-04, and TP-05; pursue new categories in eye care, dermatology, and infectious disease prevention. - **Direction for growth**: Build on the success of XDEMVY to establish a pipeline of novel therapies addressing high unmet needs, with potential to expand beyond the eye. ## Why Work Here - **Culture**: Driven by core values of teamwork, empowerment, and commitment; described as nimble, differentiated, and patient-centered. - **Work model**: Hybrid work options available; on-campus gym at headquarters. - **Perks & benefits**: Comprehensive health & wellness program (medical, dental, vision with significant employer contribution), flexible time off, paid parental leave, sabbatical program, 401(k) match, Employee Stock Purchase Plan, gym reimbursement, Calm and LifeBalance memberships, cell phone allowance, in-office meals and snacks, family-building assistance via Carrot. - **Growth opportunities**: Learning and career development resources; recognition programs; exposure to a fast-growing public company with a promising pipeline. ## Sources 1. [tarsusrx.com](https://tarsusrx.com/) 2. [tarsusrx.com/careers](https://tarsusrx.com/careers/) 3. [tarsusrx.com/our-story](https://tarsusrx.com/our-story/) 4. [ir.tarsusrx.com/investor-relations](https://ir.tarsusrx.com/investor-relations) 5. [tarsusrx.com/our-leadership](https://tarsusrx.com/our-leadership/) ## Other roles at Tarsus Pharmaceuticals - [Medical Science Liaison (MSL) - North Central](https://feeny.ai/job/medical-science-liaison-msl-north-central-tarsus-pharmaceuticals-chicago-w6wa5e6e7ebs) — Chicago Illinois, United States / Detroit Michigan, United States / Indianapolis Indiana, United States / Milwaukee Wisconsin, United States - [Associate Director, Chemical Development](https://feeny.ai/job/associate-director-chemical-development-tarsus-pharmaceuticals-irvine-california-whky9ymjtd8r) — Irvine California, United States - [Associate Director, Innovation Lab](https://feeny.ai/job/associate-director-innovation-lab-tarsus-pharmaceuticals-irvine-california-8vz9xeyyajhr) — Irvine California, United States - [Sr Director, Clinical Sciences](https://feeny.ai/job/sr-director-clinical-sciences-tarsus-pharmaceuticals-irvine-california-q60faq8s7ngt) — Irvine California, United States - [Regional Sales Director - West](https://feeny.ai/job/regional-sales-director-west-tarsus-pharmaceuticals-field-united-states-1j686mqp8756) — Field - United States - [Sr Director, Regulatory Affairs Strategy](https://feeny.ai/job/sr-director-regulatory-affairs-strategy-tarsus-pharmaceuticals-united-states-gty3prt5ea21) — United States - [Territory Leader - Santa Monica & Hollywood, CA](https://feeny.ai/job/territory-leader-santa-monica-hollywood-ca-tarsus-pharmaceuticals-los-angeles-acf59krmzz6r) — Los Angeles California, United States - [Sr Scientist - Analytical Development](https://feeny.ai/job/sr-scientist-analytical-development-tarsus-pharmaceuticals-irvine-california-d4d9tw4487tb) — Irvine California, United States - [Sr Director, Technical Operations](https://feeny.ai/job/sr-director-technical-operations-tarsus-pharmaceuticals-irvine-california-aej3r8q98pfw) — Irvine California, United States - [Sr Director, Enterprise Data & Analytics](https://feeny.ai/job/sr-director-enterprise-data-analytics-tarsus-pharmaceuticals-irvine-california-q7m4w0f4psy6) — Irvine California, United States