Director, Regulatory Affairs - remote or San Diego, CA
Mirador Therapeutics, Inc. is a clinical-stage precision medicine company focused on developing first-and/or best-in-class next-generation therapeutics for immunology and inflammation. The company’s Mirador360™ precision development engine leverages the latest advances in human genetics and data science to rapidly deliver new precision medicines for patients living with immune-mediated inflammatory and fibrotic diseases. Mirador has raised over $650 million from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by Biospace and is a Great Place to Work-Certified™ Company.
Summary
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.
Responsibilities
• 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.
• 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.
• 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
• Bachelor's degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred.
• 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.
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, flawless execution with intense 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 Veeva, Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget.
• Travel up to 5-10% may be required to meet with vendors and regulators.
The expected base pay range for this position is $175,000 – $220,000 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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Summary
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.
Responsibilities
• 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.
• 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.
• 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
• Bachelor's degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred.
• 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.
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, flawless execution with intense 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 Veeva, Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
• Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget.
• Travel up to 5-10% may be required to meet with vendors and regulators.
The expected base pay range for this position is $175,000 – $220,000 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.
#LI-remote
Working at Mirador Therapeutics | Great Place To Work®
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.
Read our Job Applicant Privacy Policy
Apply tot his job
Apply To this Job