Description

This position is responsible for the development and implementation of regulatory strategies for pipeline programs. This involves proactively identifying, assessing and mitigating regulatory risks to the plans. Will share regulatory knowledge and insight that impact product and policy development by interpreting policy and industry trends, advising on agency interactions, and sharing regulatory lessons learned in order to help users navigate policy issues and minimize regulatory risks.

Essential Functions

• Accountable for the development and implementation of the regulatory strategy for AnaptysBio’s pipeline programs.
• Serve as the FDA contact, leading creative and constructive interactions with regulatory agencies to effectively negotiate regulatory agreements, and to ensure that all projects have clearly defined regulatory paths and milestones. 
• Manage regulatory project plans and timelines for projects in accordance with project, department and corporate goals.
• Keep abreast of all pertinent laws, regulations and guidance; develop aligned recommendations for regional regulatory strategies and implementation activities and share insights that impact product and policy development on a global level. 
• Develop and implement regulatory affairs practices and policies in compliance with quality systems, and to assure adherence to global and regional requirements, and SOPs.
• Review protocols, reports and summary documents (clinical, pharmacology & toxicology) for adherence to regulatory guidelines, strategies, and commitments. 
• Manage the assembly, support the review, and submission of, regulatory documentation such as INDs, CTAs, responses, etc. ensuring consistency/completeness/adherence to standards for all regulatory submissions. 
• Ensure the quality, content and format of regulatory submissions and for communication and teamwork with project team members.
• Advise the project teams on applicable regulatory guidance's and other appropriate product regulations that impact the development of product candidates.
• Interpret and advise the project team on the application of industry regulations, the FDA review process and international regulatory requirements.

Requirements

Education & Experience: 

• BS in related scientific discipline, and 10 years of experience in regulatory affairs. International experience is a plus.
• Experience with Phase 1 through marketing application submission process. 
• Successful contribution to a major regulatory approval at a global or regional level preferred. 
• Experience in organizing and running successful FDA meetings.
• Experience with multiple regulatory disciplines (CMC, clinical, labeling, etc.).
• Demonstrated leadership ability in team/department settings.
• Proven leadership and program management experience. 

Knowledge and Competencies: 

• A scientific and clinical understanding of the regulatory sciences. 
• Demonstrated understanding of regulations and guidelines governing drug development (particularly clinical drug development) including ability to apply these to overall strategic drug development. 
• Demonstrated ability in leading the development of sound and effective regulatory strategies. Identify and communicate potential risks associated with strategy scenarios.
• Knowledge of and experience with both US and international regulatory filings.
• Experience with Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook, Adobe, and Internet Explorer.
• Effective communication and interpersonal skills, with the ability report and present experimental results and analysis to colleagues at all levels, including scientific/medical and management. Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings. Ability to respond effectively to the most sensitive inquiries or complaints. 
• Ability to work effectively in as a team player in a complex, changing environment, intensely committed to success and getting the job done well, with the additional ability of being able to build morale and group commitments to goals and objectives.
• Ability to work productively in a matrix team environment, as well as take ownership of multiple projects. 
• Ability to define issues, collect, and analyze complex data, and draw valid conclusions. 
• Ability to identify and resolve problems in a timely manner
• Ability to develop strategies to achieve organizational goals; demonstrates an understanding of organization's situation and goals; analyzes market and competition; identifies threats and opportunities; adapts strategy to changing conditions.
• Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
• Position will require domestic and international travel.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.

Work Environment

The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The noise level in the work environment is usually moderate.

May be required to travel by plane or car.

This position requires working with biological and/or chemical hazards.

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.