Vp/Senior Vp, Regulatory Affairs

(San Diego, CA)

Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360 ^TM precision development engine leverages the latest advances in human genetics and cutting-edge data science to rapidly advance new precision medicines for patients living with chronic immune-mediated inflammatory and fibrotic diseases. Launched in 2024, Mirador has raised over $400 million from leading life sciences investors and is based in San Diego, CA.

Summary 

We are seeking a highly motivated individual to head up the Regulatory Affairs function. The candidate will be responsible for leading the Regulatory Affairs function and will oversee and direct the strategic planning and execution of clinical regulatory activities essential for initiating and conducting clinical trials and securing marketing authorization. This role involves extensive interaction with regulatory agencies such as the FDA, EMA, and PMDA, seeking scientific advice and approvals, and provides cross-functional leadership for global filings, ensuring compliance with local regulatory requirements and authoring and reviewing submission documents for regulatory applications. The ideal candidate will have a successful record of approved regulatory submissions.

Responsibilities

• Set strategy, direct, plan and implement clinical regulatory activities required to initiate and conduct clinical trials and to seek marketing authorization.
• Interact with the FDA, EMA, PMDA, and other regulatory agencies to seek scientific and regulatory advice and obtain required approvals.
• Provide strong cross-functional leadership for global filings including authoring and reviewing sections of IND, CTA, NDA, MAA, and other global submission documents in support of clinical trials and marketing applications, as well as their amendments, in conformance with local regulatory requirements.
• Develop and implement cross-functional department policies, processes, work instructions, and standard operating procedures.
• Provide regulatory leadership for due diligence activities and partnering activities.
• Ensure inspection readiness efforts for regulatory activities and files.
• Manage regulatory budgets and vendors.
• Maintain current expertise in regulatory trends and operations.
• Participate as needed in technical discussions and collaborate with corresponding groups at Health Authorities to advance Regulatory Science.

Qualifications

• Bachelor’s degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred.
• 15 years or more of experience leading Regulatory Affairs function and people management experience.
• Extensive regulatory experience with clearing INDs and CTAs and gaining approvals of NDAs and MAAs.
• Demonstrated proficiencies in leading successful health authority meetings.
• Experience with autoimmune products and interacting with FDA CBER and EMA; additional experience with Skin, Gut and Lung products a plus.
• Experience in leading multidisciplinary teams.
• Strong knowledge in clinical and nonclinical regulatory science.
• Knowledgeable regarding global regulatory submission standards and publishing best practices.

Skills and Abilities 

• Excellent communication and collaboration skills across levels and functions.
• Ability to work independently and collaboratively in a highly dynamic work environment.
• Strong initiative, accountability, and willingness to take ownership and drive projects to completion.
• Ability to set priorities, work independently and deliver results in a timely manner.
• Sound strategic, technical, operational, and ethical judgment with uncompromising integrity.
• Travel, including international travel, approximately 25%.

The expected base pay range for this position is $250,000 – $375,000 (SVP – $275,000 – $390,000) 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.

All qualified applicants are considered for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, veteran status or other protected class.

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