Job Number:
HC-03613
Date Posted:
March 8, 2026
Position Title:
Director, Regulatory Affairs
Party:
N/A
Office Code:
Office/Company:
Mirador Therapeutics
Reports To:
Location:
San Diego, CA
Contact:
Salary:
$175,000 – $220,000 plus bonus, equity, and comprehensive benefits
Primary Role
Secondary Role:
Job Type:
Full Time
Description:
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.- 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.- Bachelor’s degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred.
Responsibilities:
• - 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.
Qualifications:
• - 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.
Instructions:
Email <ddress>
Other:
The expected base pay range for this position is $175,000 – $220,000 plus bonus, equity, and comprehensive benefits.
