VP, Regulatory Affairs

About this role:
 

As the Vice President, Regulatory Affairs you will assume a leadership role in the planning, execution, and communication of LeonaBio’s regulatory strategies and compliance requirements. The individual in this position will oversee, supervise, and manage the regulatory affairs function and will represent regulatory affairs on program strategy teams. Successful candidates will have an excellent understanding of the best approach to regulatory interaction and experience in setting up and maintaining regulatory relations to FDA. 

This role requires a driven individual who has the proven ability to start with the end in mind and can lead the development sections towards the successful NDA. This is your opportunity to make an impact as part of this small, but rapidly growing team. 
 

Responsibilities:
 

• Plans content, timelines, and coordination of regulatory submissions. 
   

• Drives the creation and refinement of effective and efficient processes to ensure consistency in submissions. 
   

• Identifies regulatory issues and provides solutions to keep programs on time, while maintaining the highest quality standards.
   

• Leads efforts for coordinating content and publishing documents for INDs, NDAs, and their associated maintenance.
   

• Oversees efforts to produce regulatory documents including investigator brochures, annual reports, and background documents for regulatory authority meetings. 
   

• Maintains knowledge of the current regulatory environment, contributes to the preparation of new regulatory guidance, comments on draft guidance, and communicates changes in regulatory information to teams and senior management.
   

• Prepares cross-functional teams for regulatory interactions as well as directs, develops, and delivers internal education and training activities.
   

• Assures compliance with regulatory standards and guidance documents.
   

• Prepares, submits, tracks, indexes, and archives electronic submissions.
   

• Serves as a subject matter expert and provides regulatory guidance on development and research teams. 
   

• Understands trends in regulatory affairs and takes a leadership role in assessing and communicating the impact of these requirements.
   

• Supervises external CRO medical writing and regulatory operations functions for coordinating and publishing submission documents.
   

• Develops and oversees the budget for the regulatory affairs function.
   

Requirements:
 

• A Bachelor’s degree in life sciences or related scientific discipline is required, a Master’s degree is preferred.
   

• Must have 10+ years of pharmaceutical or biotech industry experience in regulatory affairs. 
   

• Requires significant experience in supporting development stage programs (Phase I-IV).
   

• Knowledge and experience with all phases of clinical studies is required.
   

• Must have proven experience with FDA submissions, IND to NDA.
   

• Demonstrated experience in interacting with regulatory authorities and preparing cross-functional teams to engage with authorities on an ongoing basis during the development stages is required.
   

• Must have strong prioritization and problem-solving skills with the ability to juggle multiple high priority projects and to be flexible as new challenges arise.
   

• Strong facilitation, organization, analytical, and project management skills are required. 
   

• Must be comfortable working in a fast-paced and evolving company environment.
   

• Exceptionally organized, adaptable, and resourceful
   

• Strong communication, presentation, and negotiation skills.
   

• Requires experience leading, managing, coaching, and developing direct reports.
   

• Advanced skills with MS Office and Clinical Trial Management Systems required. 
   

• Endorse and promote LeonaBio’s values:  People, Perseverance, Transformation, Inclusion, Resourcefulness, Collaboration, and Integrity.
   

Placement in salary range is dependent upon experience, market rate and internal equity considerations.  
 

We offer competitive compensation and benefits designed to help you find balance, grow, and thrive at work and in life.  Benefits at a glance:
 

• Company paid medical, dental and vision coverage
   

• Company paid life and disability benefits
   

• 401(k) with company match  
   

• Flexible spending account (FSA)
   

• Employee Stock Purchase Plan
   

• Paid time off, 11 paid holidays, year-end holiday closure
   

• Professional development opportunities
   

• Flexible work environment
   

• Annual Bonus and Stock Options
   

LeonaBio is an equal opportunity employer and does not unlawfully discriminate against employees or applicants for employment on the basis of an individual’s race, color, religion, creed, sex, national origin, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline and termination.