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Mirador Therapeutics · 1 day ago

Associate Director, Regulatory Affairs - San Diego, CA

San Diego, CA

Full-time

Onsite

Lead/Staff, Director/Executive

$170K/yr - $200K/yr

8+ years exp

Mirador Therapeutics is a next-generation precision medicine company focused on immunology and inflammation. The Associate Director of Regulatory Affairs will be responsible for developing and implementing regulatory affairs strategy as part of multi-disciplinary pharmaceutical product development teams.

Health CareMedicalTherapeutics

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

Qualification

Regulatory AffairsClinical Trial StrategyRegulatory SubmissionsVeevaBiologics ExperienceAnalytical SkillsMulti-taskingCommunication SkillsLeadership Skills

Required

Bachelor's degree required, with an advanced scientific degree (PhD, PharmD) strongly preferred

8 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; e.g., biologics, drug/device combination products

Experience with complex clinical trial designs

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