Sr Regulatory Affairs Associate, CMC

Job Description

Kite is relocating its employees from Santa Monica to Oceanside, Thousand Oaks, or El Segundo, CA offices starting in January 2027. Applicants should consider this relocation.

Responsibilities

• Prepare moderately complex regulatory submissions requiring interactions with departments outside of Regulatory Affairs CMC for investigational and commercial products in line with ICH requirements, regional requirements, and scientific and company policies and procedures.
• Support operational and life cycle management of regulatory CMC submissions in support of global commercial and clinical programs.
• Identify CMC risk areas and suggest alternative scenarios and course of action.
• Act as Regulatory CMC representative on cross-functional project teams by applying knowledge of regulations and interpreting technical regulatory guidelines to ensure regulatory submissions are compliant with applicable regulations.
• Ensure CMC-specific registered technical details are updated and maintained.
• Develop and acquire required regulatory skills and knowledge under guidance of immediate manager.
• Initiate or contribute to local process improvements relating to Regulatory Affairs CMC function.
• Perform regulatory assessments for change controls and supplier notifications within the Quality Management System to determine regulatory impact, reporting category, and submission requirements.
• Manage Regulatory CMC commitments made to Health Authorities.
• Support Annual Product Review or Vector Product Review for all products.
• Participate in group meetings and present project status updates and strategic approaches to moderately complex programs.

Requirements

• Bachelor’s Degree in a relevant field with 5 years of relevant experience in Regulatory Affairs CMC and/or biopharmaceutical industry, or 3 years of relevant experience with a Master’s Degree.
• Knowledge of ICH requirements and understanding of global trends in CMC Regulatory Affairs.
• Excellent organizational skills, detail-oriented, and adaptable to frequent changes in product activity.
• Strong interpersonal, verbal, and written communication skills.
• High energy level, positive outlook, and willingness to take initiative to achieve personal and organizational goals.
• Professionalism, ethics, and integrity.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based on changing priorities.

People Leader Accountabilities

• Create Inclusion: Model inclusion and embed diversity in team management.
• Develop Talent: Understand employee skills, experience, aspirations, and potential, and coach them on performance and growth.
• Empower Teams: Align goals, purpose, and organizational objectives, and hold teams accountable. Provide support to remove barriers and connect them to broader ecosystem.

Pay and Benefits

The salary range for this position is $115,260.00 - $149,160.00. Kite considers various factors when determining base compensation, including experience, qualifications, and geographic location. Actual compensation may vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans. For more information, visit: https://www.gilead.com/careers/compensation-benefits-and-wellbeing.