ROLE: Vice President Regulatory Affairs

DEPARTMENT: Regulatory Affairs

REPORTING TO: Chief Medical Officer

LOCATION: The Ambros corporate office or remote from the Employee’s home office

SALARY BAND: $275,000 to $335,000 with a 30% target bonus. Final compensation will be commensurate with the candidate’s experience, education, skills, and overall alignment with the role’s requirements. 

EQUITY GRANT ELIGIBLE: Yes

POSITION SUMMARY:

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.

ESSENTIAL DUTIES AND 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.

MINIMUM EXPERIENCE, EDUCATION, CERTIFICATIONS, & LICENSES:

• 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.
• 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.
• 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.

SKILLS & QUALIFICATIONS:

• 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).

WORK LOCATION AND TRAVEL REQUIREMENTS:

This position is based from an Ambros corporate office or remote from the Employee’s home office, subject to Company policy and business needs. If remote, a dedicated home office space that is professional in appearance, quiet, and secure where confidential conversations can occur and a high-quality high-speed internet connection are required.

Regardless of primary work location, the role requires in-person presence approximately once per month for multi-day meetings at the corporate headquarters or other designated locations, as determined by business or department priorities.

Regular domestic and international travel is required, including overnight stays. Travel expectations may reach up to 20%, depending on operational priorities and Company needs.

PHYSICAL REQUIREMENTS & ENVIRONMENTAL CONDITIONS

This position is primarily performed in a professional office or home-office setting.

With or without reasonable accommodation, the employee must be able to:

• Operate a computer and standard office equipment.
• Communicate effectively in person, via telephone, and through video conferencing platforms.
• Travel independently, including overnight and international trips, and travel by personal vehicle and transit systems.
• Navigate office environments and other professional settings.

Additional requirements include:

• Prolonged periods of sitting, standing, and walking.
• Occasional lifting or carrying of items up to 20 pounds.
• Ability to read, comprehend, and apply policies, procedures, and regulations written in English.
• Ability to write clear, factual, and grammatically correct communications and reports in English.
• Ability to use logic and data for problem-solving and to exercise sound judgment.

EQUAL EMPLOYMENT OPPORTUNITY

As an equal opportunity employer, Ambros is committed to providing all applicants and employees with equal access to employment opportunities, regardless of sex, race, age, color, national origin, ancestry, disability, pregnancy, religion, genetic information, sexual orientation, transgender status, gender identity, marital status, military or veteran status, or any other characteristic protected by applicable law. All employees, officers, and representatives of Ambros are expressly prohibited from engaging in unlawful discrimination, harassment, or retaliation.

Consistent with all applicable requirements, Ambros will reasonably accommodate any qualified individual with a disability if such accommodation would allow the individual to perform the essential functions of the job, unless doing so would create an undue hardship on the Company.

Ambros also follows all applicable federal, state, and local laws governing work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and Immigration Reform and Control Act. Ambros is an E-Verify employer.

REASSIGNMENT OF DUTIES AND AT-WILL EMPLOYMENT

Nothing in this job description restricts Ambros’ right to assign or reassign duties, responsibilities, and work locations of this role at any time in its sole discretion. While this job description generally reflects Ambros’ current assessment of the essential functions for this role, it is not intended to be a complete list of the duties and responsibilities of this role, and it does not limit or restrict the duties and responsibilities that may be assigned from time to time.

Employment with Ambros is “at-will,” meaning that either the Company or the employee may terminate the employment relationship at any time, with or without cause or notice, reason, or justification, subject to applicable law.