What are the responsibilities and job description for the Senior Director, Regulatory Affairs position at Mirador Therapeutics, Inc.?
Mirador is a next-generation precision medicine company focused on immunology and inflammation. The company’s Mirador360
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
The Senior Director, Regulatory Affairs, within the Regulatory Affairs and Quality organization, is responsible for the 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, biologic, 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, biologic 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
Skills and Abilities
The expected base pay range for this position is $210,000 - $265,000 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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Salary : $210,000 - $265,000
