Sr. Director, Regulatory Affairs

Location:
This position can be located in
Thousand Oaks, CA, San Francisco Bay Area, CA or Washington, D.C. area
Overview:
Reporting to the Senior Vice President of Regulatory, the Senior Director of Regulatory Affairs will support regulatory strategy and lead regulatory execution for the company’s development programs, ensuring compliance with global health authority requirements (FDA, EMA, and other regulatory agencies). This role will be responsible for developing and implementing regulatory activities to support the clinical development plans including leading submissions, managing regulatory vendors, support of regulatory interactions, and providing
regulatory guidance to cross-functional teams.
Responsibilities:
Regulatory Strategy & Leadership
Lead execution and implementation
of regulatory strategies to support product development.
Support regulatory interactions with global health authorities, including FDA, EMA, MHRA, and others.
Provide regulatory input into clinical development plans, study designs, labeling strategies 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.).
Ensure timely
regulatory submissions are complete and
accurate.
Maintain current knowledge of applicable regulatory requirements and ensure organizational compliance.
Lead/support preparation 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, and leadership teams 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/supporting FDA 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 experience ideal
Experience with small molecules and pain (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 experience preferred
Excellent written and verbal communication skills
Must display strong analytical and problem-solving skills.
Attention to detail is essential.

Employment type
Full-Time

Work arrangement
No