About the Role

Reporting to the VP Regulatory Affairs, the Director, Regulatory Operations will be a key contributor to Tarsus Pharmaceuticals' Regulatory Affairs group with accountability for all submission-related activity. The individual will be instrumental in establishing a Regulatory Operations function within the company and will function as the Regulatory Operations Lead for company submissions and implementation of regulatory operations infrastructure and processes within Tarsus.

Let's talk about some of the key responsibilities of the role:

• Lead the establishment of the regulatory operations function withing the regulatory department at Tarsus, including the identification and implementation of role-specific infrastructure, software and policies and procedures.
• Lead the preparation of regulatory submission documents in compliance with global regulatory requirements for different application types (eg, IND, NDA/BLA, MAA, , CTA, NDS).
• Work with subject matter experts and cross-functional departments to analyze and develop processes that support business needs using either Sharepoint or the Veeva platform to generate and archive compliant regulatory documents.
• Prepare or oversee the preparation of electronic submission ready documents (format/edit/proof) and create bookmarks and hyperlinks according to guidance and processes.
• Word document processing, development and management, PDF publishing/QC review, and archiving consistent with global regulatory requirements for different application types.
• Develop a regulatory style guide and ensure consistency across regulatory submission documents following the regulatory style guide. Provide technical expertise to cross-functional teams on format, style, and structure of compliant documents for electronic submissions.
• Prepare scheduling and planning submission timelines, and collaborate with Program Management on major submission planning, as appropriate.
• Coordinate with external publishing vendors and consultants for on-time delivery of high-quality regulatory submissions.
• Conduct final review of published submissions to ensure consistency and compliance with regulatory requirements.
• Execute regulatory information management tasks including file transfer, storing, tracking, and archiving of regulatory submission documents/.
• Lead the development of Regulatory Operations processes (SOPs, work instructions, guidelines) for preparing submissions and regulatory information management.
• Maintain current knowledge of global regulatory submission requirements.

Factors for Success:

• Bachelor's degree and at least 10 years of experience in Regulatory Operations with specialized skills in electronic submissions.
• Hands-on experience and expert-level skills in Word processing, formatting, and PDF publishing for electronic submissions.
• In-depth experience with electronic document management and publishing systems (eg, Veeva Vault RIM, Box, SharePoint, Lorenz DocuBridge), eCTD Validation and viewing tools (eg, Lorenz eValidator,) and other publishing and QC tools (PDF Tools, TRS Toolbox), global regulatory submissions, or other experience directly related to Regulatory Operations.
• Committed to producing high-quality and timely deliverables.
• Demonstrate flexibility, patience, and good verbal, written, and interpersonal communication skills.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, and occasional catered meals. We provide a hybrid work environment.
• 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 Vice President, Regulatory Affairs
• Some travel may be required – up to 25%

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $174,000 - $243,600 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://alliantbenefits.cld.bz/tarsus2024BenSnapshot

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