Vice President Regulatory Affairs

Ambros Therapeutics, Inc.•Irvine, CA

3h•$275,000 - $335,000•Hybrid

About The Position

Reporting to the Chief Medical Officer (“CMO”), the Vice President Regulatory Affairs will play a critical strategic, leadership, and contributor role in developing and executing regulatory strategies and tactics to support Ambros Therapeutics, Inc.’s (“Ambros” or the “Company”) clinical development programs and future commercial success. This leader will oversee all regulatory activities including submissions, interactions with health authorities, and compliance with applicable regulations in the US, and, as applicable, globally. This role will serve as the Company’s primary liaison to the U.S. Food and Drug Administration (“FDA”) and other regulatory bodies as needed and will provide cross-functional leadership to ensure that all development and registration activities align with the Company’s strategic objectives and regulatory requirements.

Requirements

Advanced degree (PharmD, PhD, MD, or MS) in a scientific or regulatory discipline required.
Minimum of 8 to 10 years of progressively increasing responsible regulatory experience in the biotechnology or pharmaceutical industry.
Extensive experience leading IND and other regulatory submissions relevant to a medicine in late-stage development through filing, approval and commercialization.
Deep knowledge of US regulatory requirements, including FDA and International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (“ICH”) guidelines.
Proven ability to design and implement regulatory strategies for small molecules; sterile injectable experience is a plus.
Strong leadership background with experience building and managing regulatory teams in a fast-paced, matrixed environment.
Strategic thinker with demonstrated ability to anticipate regulatory trends and shape development strategies accordingly.
Exceptional leadership, collaboration, and communication skills with ability to influence across all levels of the organization.
Strong project management capabilities and proven ability to manage multiple complex priorities simultaneously.
Expert-level knowledge of regulatory submission processes, including Electronic Common Technical Document (“eCTD”) and electronic publishing.
Excellent analytical and problem-solving skills; adept at making sound judgments under pressure.
Highly skilled at the translation of complex data into clear, credible narratives.
Superior verbal, written, and presentation communication skills in English, with the ability to engage effectively across all levels of the Company and with external stakeholders (e.g. Health Authorities, regulators, and medical and scientific experts).
Upholds high ethical standards and maintains scientific and regulatory integrity in all activities.
High degree of professionalism and commitment to operational excellence.
Must have knowledge of and be willing to comply with all regulatory requirements, compliance standards and regulations, Ambros’ SOPs and polices, and industry best practices consistent with the role and Company policies.
Ability to read and comprehend complex materials, including medical, scientific, and regulatory literature, policies, procedures, and instructions in English; write reports and memos; use logic and data to solve problems; assess needs and take appropriate actions; all with reasonable independence, business judgment, and professional discretion.
Proficiency in Microsoft Office Suite and document management systems (e.g., Veeva).

Nice To Haves

Experience in orphan diseases and FDA-related regulations, policies and approaches on pediatric written requests is a plus.
Extensive experience with successfully interacting with FDA; experience the Division of Anesthesia, Addiction Medicine and Pain Medicine (DAAP) or General Endocrinology is a plus; experience with other global regulatory authorities is a plus.
Proven ability to design and implement regulatory strategies for small molecules; sterile injectable experience is a plus.

Responsibilities

Lead the development and implementation of comprehensive regulatory strategies for Ambros’ clinical and manufacturing programs, promotional review, and regulatory filings.
Play a leadership role, along with the VP Clinical and other functions in the preparation, review, and submission of all regulatory filings including Investigational New Drug (“IND”), New Drug Application (“NDA”), and Annual Reports,” and briefing packages for Health Authority meetings. Participate in the development and review of Investigator’s Brochures (“IB”), Development Safety Update Report (“DSUR’”) and similar documents.
Serve as the company’s primary liaison with the FDA and other global health authorities; coordinate and lead key regulatory interactions and negotiations.
Direct and ensure regulatory compliance across all development stages and geographies.
Develop and update, with cross functional team input, target product profile(s)
Assess existing data from legacy companies that contribute to an NDA and assess for actions needed to gain alignment with the FDA.
Partner with cross-functional leadership (Clinical Sciences, Clinical Operations, CMC, toxicology, Safety, Medical Writing, and Quality) to ensure robust and compliant regulatory documentation and submissions.
Provide strategic input to senior management on regulatory pathways, risk assessment, and mitigation plans for global development programs.
Lead preparation for and execution of regulatory meetings
Oversee regulatory intelligence and proactively assess evolving US regulations (and global, as relevant), guidelines, and policies that impact Ambros’ programs.
Guide the development of internal regulatory procedures, Standard Operating Procedures (“SOPs”), and documentation standards in partnership with Quality.
Manage relationships with external consultants, Contract Research Organizations (“CROs”), and publishing vendors to ensure timely and accurate submission delivery.
Contribute to due diligence and regulatory strategy assessments for potential business development or partnership opportunities.
Recruit, develop, lead and mentor a high-performing Regulatory Affairs team as Ambros progresses towards an NDA.
Partner with Legal, Quality, and Clinical functions to maintain inspection readiness and ensure compliance with GXP standards.
Provide regular regulatory updates to executive management and the Board of Directors.
Other duties as assigned.