Principal Regulatory Affairs Specialist

The Principal Regulatory Affairs (RA) Specialist, will manage and lead regulatory submissions and develop regulatory strategies for investigational and marketed products by interacting effectively within a cross-functional project team of internal and external subject matter experts. The scope of regulatory submissions will focus on CMC and will also include clinical and non-clinical submission. This position serves as the regulatory representative on relevant project teams and as the regulatory contact with health authorities.

• Actively understand and interpret industry trends and health authority's expectations in areas related to CMC, non-clinical and clinical. Influence and communicate how these trends align with strategic department direction and vision.
  
• Develop regulatory strategy for CMC, non-clinical, and clinical and define the corresponding submission deliverables for assigned development projects or programs and for post- approval changes and ensure implementation of agreed upon strategies. 
  
• Provide technical and strategic direction on CMC, non-clinical and clinical issues throughout product development and commercialization.
  
• Monitor changes to development plans and provide regulatory guidance to teams 
  
• Represent Regulatory Affairs at various project team and working group meetings.   
  
• Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical issues.    
  
• Collaborate with equivalent cross-functional colleagues concerning CMC, non-clinical and clinical interests to meet project milestones.
  
• Lead in regulatory due diligence activities as assigned.
  
• Act as a direct point of contact with FDA and participate in meetings for CMC, non-clinical and clinical related issues.
  
• Execute strategies to ensure rapid and timely approval of applications for new and marketed products.
  
• Maintain cross-functional awareness of and expertise in ICH, FDA and EU guidelines related to regulatory topics. 
  
• Liaison with business partners on regulatory matters on assigned programs
  
• Collaborate with RA senior management to create and implement policies, processes, and procedures supporting the department goals and objectives.
  

• 505 b2 and generic experience along with managerial experience is preferred.
  
• Experience with international health authorities is preferred. 
  
• Extensive knowledge of US CMC regulatory requirements and the ability to apply knowledge both strategically and operationally to development projects and marketed product regulatory issues.
  
• Comprehensive knowledge of drug development process, pharmaceutical technology, drug manufacturing processes and related issues, drug laws, regulations and guidelines.
  
• Comprehensive knowledge and experience in CMC sections for investigational and marketed product submissions for FDA. Must have strong strategic and critical thinking, leadership, diplomacy and negotiation skills.
  
• Excellent written and verbal communications skills.
  
• Must be able to effectively communicate with scientists at all levels.
  
• Demonstrated ability to work in and lead effectively in matrix teams.
  
• Strong organization and time management skills.
  
• Demonstrated ability to influence based on experience, facts and data.