Director, Regulatory Affairs

Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.

Summary

The Associate Director of Regulatory Affairs, within the Regulatory Affairs and Quality organization, is responsible for development and implementation of regulatory affairs strategy as a member of multi-disciplinary pharmaceutical product development teams.

Responsibilities

• Represent Regulatory Affairs in assigned project meetings and provide regulatory guidance to cross-functional project teams as appropriate; leverage experience in drug and device regulatory affairs to provide guidance to colleagues for preparation of regulatory documents.
• Serve as Regulatory Affairs contact for external parties (for example, CROs) involved in the conduct of global clinical trials.
• Develop and implement global regulatory strategy for drug and device submissions to support clinical trials and registration in accordance with applicable regulations/guidelines (for example, U.S. FDA, EMA, ICH, ISO, etc.).
• Plan, prepare, author, and/or review submissions (for example, IND, CTA, BLA, NDA, MAA, IDE, PMA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
• Oversee interactions with vendor for electronic submissions.
• May serve as primary liaison with FDA (and other health authorities, as appropriate) for day-to-day interactions.
• Contribute to the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks.
• Communicate project updates and risks to senior Regulatory management and stakeholders across the organization.
• Tracking regulatory commitments and deliverables while coordinating with internal and external staff to ensure timely submissions.
• Coordinate and prepare responses to requests for information from health authorities.
• Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings with health authorities.
• Provide input into development of internal documentation practices and systems.
• Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
• Participate in due diligence evaluations of potential in-license/partnering opportunities.
• Initiate and contribute to the development of policies and procedures in alignment with GxPs, Guidance, and corporate objectives.

Experience and Qualifications

• Bachelor’s degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred.
• 10 or more years of experience in Regulatory Affairs; experience in therapeutic areas of company focus is a plus.
• Regulatory Affairs experience with multiple therapeutic modalities, biologics required. Drug/device combination products preferred.
• Experience with complex clinical trial designs.

Skills and Abilities

• Unquestionable integrity, be able to inspire trust and exhibit the highest ethical standards.
• Excellent communication, verbal and written, and interpersonal skills with strong ability to interact with internal teams and partners across all levels of the organization.
• Ability to effectively present information and respond to questions from all levels of the organization.
• Sense of urgency, flawless execution with intense focus on accuracy and accountability.
• Self-starter, highly motivated, assertive, driven, and hands-on leader.
• Ability to multi-task in a fast-paced, entrepreneurial, smaller company environment.
• Operate collaboratively with colleagues across functional areas in a science-driven environment.
• Ability to work well under pressure and meet time sensitive deadlines.
• Ability to work across locations and time zones.
• Highly proficient using Veeva, Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget.
• Travel up to 5-10% may be required to meet with vendors and regulators.

The expected base pay range for this position is $175,000 – $220,000 plus bonus, 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. This range may be modified in the future.

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