Senior 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, t he 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 implement ation
• of regulatory strategies to support product development .

S upport 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

D irect 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.