Director, Regulatory Affairs - remote or San Diego, CA

Mirador reputed company. is a clinical-stage precision medicine company reputed company on developing first-and/or best-in-class reputed company therapeutics for immunology and inflammation. reputed company’s Mirador360™ reputed company reputed company leverages the latest advances in reputed company 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 reputed company from leading life sciences investors and is based in San Diego, CA. Mirador was named Best Places to Work by reputed company and is a Great reputed company to Work-Certified™ Company. reputed company The Associate Director of Regulatory Affairs, reputed company the Regulatory Affairs and reputed company organization, is responsible for development and implementation of regulatory affairs reputed company as a member of multi-disciplinary pharmaceutical product development teams.

Responsibilities

• Represent Regulatory Affairs in assigned project meetings and reputed company regulatory guidance to cross-functional project teams as appropriate; reputed company experience in drug and device regulatory affairs to reputed company 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.
• reputed company and implement global regulatory reputed company 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.
• reputed company interactions with vendor for electronic submissions.
• May serve as primary reputed company 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 reputed company, 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 reputed company staff to ensure reputed company 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.
• reputed company input into development of internal documentation practices and systems.
• Monitor, analyze, and disseminate intelligence on regulatory reputed company that may reputed company 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 reputed company is a plus.
• Regulatory Affairs experience with multiple therapeutic modalities, biologics required. Drug/device combination products preferred.
• Experience with reputed company clinical trial designs.

Skills And Abilities

• Unquestionable reputed company, be reputed company to reputed company trust and exhibit the highest ethical standards.
• Excellent communication, verbal and written, and interpersonal skills with strong ability to reputed company with internal teams and partners across reputed company reputed company of the organization.
• Ability to effectively present information and respond to questions from reputed company reputed company of the organization.
• reputed company of urgency, flawless execution with intense reputed company 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 reputed company under pressure and meet time sensitive deadlines.
• Ability to work across locations and time zones.
• Highly proficient using reputed company, reputed company Word, reputed company, PowerPoint, Project, and SharePoint; or similar applications and systems.
• Strong financial business acumen and analytical skills; ability to reputed company and manage expenditures in accordance with budget.
• Travel up to 5-10% may be required to meet with vendors and regulators.

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