Director, Regulatory Affairs

Location:           

 This position canbe located in
Thousand Oaks, CA,San Francisco Bay Area,CA or Washington, D.C. area

Overview: 

Reporting to the Vice President of Regulatory,the Director of Regulatory Affairs willsupport regulatory strategy andlead regulatoryexecution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role willbe responsible for developing and implementing regulatoryactivities to support the clinical development plans including leading submissions, managing regulatoryvendors, support of regulatoryinteractions, andproviding
regulatoryguidance to cross-functional teams.  

Responsibilities: 

Regulatory Strategy & Leadership 

• Lead execution andimplementation
  ofregulatory strategies to support product development. 

• Support regulatory interactionswith global health authorities, including FDA, EMA, MHRA, and others. 

• Provide regulatory input into clinical development plans, study designs, labelingstrategies etc. 

• Anticipate and mitigate regulatory risks; develop contingency plans as needed. 

Submissions & Compliance 

• Oversee the preparation, review, and submission of high-quality regulatory documents (INDs, CTAs, NDAs, briefing documents, etc.). 

• Ensuretimely
  regulatory submissions are complete and
  accurate. 

• Maintain current knowledge of applicable regulatory requirements and ensure organizational compliance. 

• Lead/supportpreparation and management of regulatory meeting requests and briefing documents for FDA Type B/C meetings and equivalent ex-US interactions. 

Cross-Functional Collaboration 

• Partner with Clinical Development, CMC, Nonclinical, Quality, andleadershipteams to integrate regulatory considerations. 

• Provide regulatory guidance on study protocols, statistical analysis plans, and clinical trial conduct. 

• Quality mindset
  regarding CMC submissions and inspections. 

Requirements:  

• Bachelor’s, Master’s, PharmD, or PhD, preferably in life sciences  

• Minimum of 8 years of Regulatory experience 

• Direct experience leading/supportingFDA interactions  

• Ability to oversee regulatory activities and manage processes from research/discovery, CMC, and clinical and manage process from clinical development through to commercialization planning 

• US registration experienceideal 

• Experience withsmall molecules andpain(or similar area) is preferred 

• Experienced with IND submission and maintenance  

• Knowledge of US procedures (fast to market procedures would be an advantage) 

• Familiarity with EU CTA/MAA regulatory processes preferred 

• Regulatory Project Management experiencepreferred 

• Excellent written and verbal communication skills
• Must display strong analytical and problem-solving skills. 
•  Attention to detailisessential.