Global Regulatory Strategy Lead for Submissions

Exelixis; Alameda (CA); On-site; USD 195,000 - 277,500; Full time

Benefits offered by this job

401k plan with company contributions

Group medical, dental and vision plans

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase plan

Long-term incentives

Accrued vacation days (15 in first yr)

Job summary

Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement global regulatory strategies that align with asset and corporate goals. You will ensure timely preparation of organized submissions and translate regulatory requirements into practical plans.

You will interact with authorities, lead cross-functional teams, review trial documentation, and coordinate submissions across regions while driving risk mitigation and ensuring high-quality messaging in all

Qualifications

• Bachelor's degree in life sciences with significant regulatory experience.
• Master's or PhD preferred with relevant regulatory track record.
• Strong communication and leadership skills across global teams.

Responsibilities

• Interact directly with regulatory authorities to discuss strategies.
• Conduct regulatory intelligence and risk assessments for scenarios.
• Represent Regulatory Affairs on cross-functional teams for development programs.
• Coordinate planning, review, and submission of CTAs and regulatory documents.
• Review trial-related documentation for regulatory compliance.
• Oversee electronic and paper submissions to health authorities across regions.

Skills

Regulatory strategy

Regulatory submissions

Cross-functional leadership

Regulatory risk assessment

Stakeholder communication

Education

Bachelor's degree in life sciences

Master's degree in life sciences

PhD in related discipline

Job description

Exelixis is seeking a Senior Regulatory Affairs role in California to develop and implement global regulatory strategies that align with asset and corporate goals. You will ensure timely preparation of organized submissions and translate regulatory requirements into practical plans.

You will interact with authorities, lead cross-functional teams, review trial documentation, and coordinate submissions across regions while driving risk mitigation and ensuring high-quality messaging in all