Associate Director, Regulatory Affairs CMC - 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 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.

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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