Regulatory Submissions Operations Director

Exelixis, Inc.; Alameda (CA); On-site; USD 157,500 - 222,500; Full time

Benefits offered by this job

401k plan with generous contributions

Group medical, dental and vision coverage

Flexible spending accounts

Discretionary annual bonus program

15 accrued vacation days in the first year

17 paid holidays

Up to 10 sick days per year

Job summary

Exelixis, Inc. is seeking an Associate Regulatory Operations Director in Alameda, CA. This role is responsible for overseeing submission activities and managing the submission forecast. The ideal candidate will have substantial experience in regulatory operations and will work collaboratively with cross-functional teams to ensure high-quality regulatory submissions.

The position requires a Bachelor's degree with eleven years of experience, or a Master's with nine years, or a PhD with five. Extensive knowledge in regulatory guidelines is essential, alongside strong communication and project management skills.

Qualifications

• Minimum of eleven years of related experience for Bachelor's or nine for Master's.
• Minimum of five years for PhD graduates.
• Strong knowledge of regulatory submission processes.

Responsibilities

• Oversee regulatory submission planning for various applications.
• Collaborate with cross-functional teams for project plans.
• Develop submission planning best practices.

Skills

Regulatory framework knowledge

Project management

Verbal and written communication

Interpersonal skills

Problem-solving

Education

Bachelor’s degree in related discipline

Master’s degree in related discipline

PhD in related discipline

Job description

Exelixis, Inc. is seeking an Associate Regulatory Operations Director in Alameda, CA. This role is responsible for overseeing submission activities and managing the submission forecast. The ideal candidate will have substantial experience in regulatory operations and will work collaboratively with cross-functional teams to ensure high-quality regulatory submissions.

The position requires a Bachelor's degree with eleven years of experience, or a Master's with nine years, or a PhD with five. Extensive knowledge in regulatory guidelines is essential, alongside strong communication and project management skills.