Global Regulatory Strategy Director

Regulatory Toolkit; Alameda (CA); On-site; USD 195,000 - 278,000; Full time

Benefits offered by this job

401k plan with generous company match

Medical, dental, and vision coverage

Life and disability insurance

Flexible spending accounts

Discretionary annual bonus program

Stock purchase program

Long-term incentives

Vacation days

Paid holidays

Sick days

Job summary

Exelixis is seeking a senior Regulatory Affairs professional to develop and implement global regulatory strategies that align with asset and corporate goals and health authority requirements.

You will coordinate multi-regional submissions, review clinical documentation for compliance, and lead regulatory activities across early and late-stage programs. This role involves collaboration with vendors and internal teams to mitigate regulatory risk and support business objectives.

Qualifications

• Delivers high quality work within established timelines.
• Applies broad regulatory knowledge to develop innovative approaches.
• Communicates updates clearly and effectively to stakeholders.
• Collaborates with internal and external partners to resolve issues.
• Leads initiatives that align regulatory efforts with business goals.

Responsibilities

• Interact directly with regulatory authorities.
• Conduct regulatory intelligence and risk assessments for various scenarios.
• Represent Regulatory Affairs in cross-functional teams to set strategies.
• Plan, review, submit, and maintain CTAs in multiple regions.
• Review trial-related docs for regulatory alignment and quality.
• Coordinate and evaluate regulatory submissions to ensure completeness and messaging.
• Oversee regulatory submission processes, including INDs and NDAs/BLA.
• Contribute to SOPs and internal work instructions.
• Lead multiple assets or studies and liaise with stakeholders.

Skills

Regulatory strategy

Regulatory intelligence

Cross-functional collaboration

Communication (verbal & written)

Interpersonal skills

Team leadership

Problem solving

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

PhD in related discipline

Equivalent combination of education and experience

Job description

Exelixis is seeking a senior Regulatory Affairs professional to develop and implement global regulatory strategies that align with asset and corporate goals and health authority requirements.

You will coordinate multi-regional submissions, review clinical documentation for compliance, and lead regulatory activities across early and late-stage programs. This role involves collaboration with vendors and internal teams to mitigate regulatory risk and support business objectives.