Primary Role

The Director/Sr. Director of Regulatory Affairs is responsible for developing and directing Alto Neuroscience’s regulatory strategy, objectives, policies, and programs from IND planning through NDA, PDUFA, and commercial life cycle in collaboration with the leadership team. This position will serve as the regulatory lead for Alto Neuroscience developing and providing strategic regulatory direction and guidance to R&D on corporate projects and key strategic business initiatives to achieve corporate objectives. This role will also drive the operational aspects of regulatory compliance and submissions for all programs including discovery,

non-clinical, CMC, engineering, and clinical. This position reports to the Chief Medical Officer and will work closely with the Company’s cross-functional program teams and other functions throughout the organization (e.g., legal, commercial, business development).

Duties And Responsibilities

• Act as primary strategic contact with the FDA and other regulatory agencies, as applicable, to enable execution of company regulatory goals
• Lead the development of strategic plans and tactical implementation leading to the creation and submission of regulatory documents (INDs, NDAs, CTAs, MAAs, supplemental NDAs, and other relevant regulatory filings) working in close collaboration with other functions such as non-clinical, CMC/manufacturing, clinical, data science, engineering, commercial, and legal
• Lead in the preparation and assembly of clinical submissions for regulatory agencies (protocols, informational amendments, annual reports and safety reports)
• Provide guidance to business development regarding critical evaluation of potential product opportunities supporting strategic partnering and licensing activities
• Manage external consultants based on the stages of the business
• Develop and design robust regulatory processes and procedures, and budget forecasting based on expert understanding, industry experience, and insight into the future direction of regulatory policy
• Provide expertise in the interpretation, guidance and training of FDA regulations and regulatory advice to other functional groups and executive management
• Troubleshoot and resolve regulatory management and scientific issues on projects as required in collaboration with functional groups
  
  

LOCATION:

Mountain View, Remote, Hybrid depending on candidate’s location

Salary

$240K-$280K Annually

Qualifications

• Bachelor’s degree in a scientific discipline or equivalent. Advanced degree preferred (MS, PhD, PharmD, MD)
• At least 10 years of experience in pharmaceutical/biotechnology industry, of which a minimum of 7 years in Regulatory Affairs with leadership and/or management experience
• Extensive experience working with the FDA’s Center for Drug Evaluation and Research (CDER) preferably with the Division of Psychiatry Products and other regulatory authorities, with successful NDAs (recent experience preferred) and commercial planning highly desired along with equivalent international regulatory experience
• Experience working with the FDA’s Center for Devices and Radiological Health (CDRH) on medical devices, software as a medical device, and drug/device combination programs is preferred
• Experience with preparation and conduct of FDA advisory committee meetings preferred
• Experience and/or active involvement in joint ventures, highly collaborative partnerships, and in/outlicensing business opportunities is a plus
• Strong leadership and organizational skills as well as strong strategic and analytical abilities, diplomacy, negotiation, and excellent oral and written communications skills
• Writing skills that meet regulatory requirements and standards for documentation, including the ability to effectively describe complex situations
• Strong understanding of the global pharmaceutical drug development and regulatory environment particularly within the FDA
• Ability to communicate effectively, build cross-functional relationships, and work collaboratively with other groups
• Must be adept working in a mission driven environment