Associate Director, Regulatory Affairs CMC

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 inSan Diego, CA.

Summary

We are seeking a motivated individual to join our Regulatory Affairs team and be responsible for leading development and implementation of regulatory CMC strategy primarily for biological assets.

Responsibilities

• Responsible for working with the CMC team to develop and implement the regulatory CMC strategy for development stage and marketed products, for assigned programs, in alignment with applicable regulations/guidelines (e.g., FDA, EMA, ICH, etc.), global development strategy, and business strategy.
• Participate in cross-functional matrixed project teams, which include colleagues from regulatory, quality and manufacturing (compliance and technical), to support the planning of CMC/manufacturing changes (pre- and post-approval).
• Plan, prepare, author, and/or review CMC-focused content for health authority submissions (e.g., scientific advice briefing packages, CTA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, post-approval registration changes, and/or labeling of pharmaceutical products.
• Coordinate, contribute to, and/or prepare CMC responses to requests for information from health authorities.
• Responsible for regulatory affairs assessment of CMC-related changes.
• Drive strategy for M3 content for IND/IMPD/CTA and NDA/BLA/MAA in collaboration with CMC and Quality colleagues.
• Initiate and/or manage relationships with external regulatory affairs CMC consultants, as required.
• Monitor, analyze, and disseminate intelligence on regulatory affairs CMC matters that may affect ongoing development programs.
• Participate in due diligence evaluations of potential in-license/partnering opportunities.

Experience and Qualifications

• Bachelor's degree required, with a PhD strongly preferred.
• 8 years or more of experience in Regulatory Affairs CMC (or related role).
• Global Regulatory Affairs CMC experience with biologics.
• Demonstrated track record of successful submissions to and interactions with FDA, EMA, and other health authorities.

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, 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 Microsoft Word, Excel, PowerPoint, Project, SharePoint, Starting Point templates, or similar applications and systems.

The expected base pay range for this position is $170,000 - $210,000 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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