Associate Regulatory Operations Director
Exelixis
June 26, 2026
Remote friendly (Alameda, CA)
United States
Operations
Associate Regulatory Operations Director – Job Purpose
- Oversee submission activity for the submission portfolio, manage submission forecast and staffing for upcoming submissions.
- Use in-depth knowledge of global regulatory submission requirements to guide Regulatory Affairs and cross-functional teams toward timely, high-quality filings.
- Identify areas impacting submission timelines, drive process efficiencies, and oversee/guide the Veeva RIM suite with best practices.
Essential Duties and Responsibilities:
- Oversee planning of regulatory submissions (INDs, NDAs, BLAs, supplemental applications, etc.) in electronic format.
- Ensure submission processes and best practices; clarify timelines and deliverables.
- Create/maintain global regulatory submission project plans; manage deliverable timelines; align roles/responsibilities; assess issues/risks/impacts from strategy/timeline changes; provide transparent status updates.
- Lead cross-functional team efforts to optimize submission processes.
- Develop submission planning best practices and implement major submission timelines.
- Partner with Vice President, Regulatory Operations on department best practices/ways of working.
- Identify IT solutions to enhance Regulatory Operations systems (e.g., project planning tools, Veeva RIM).
- Contribute to regulatory process documentation (SOPs/work instructions/guidelines) and departmental initiatives.
- Mentor Regulatory Operations team members on submission planning best practices.
- Review and interpret regulatory guidelines.
Qualifications:
- Bachelor’s degree in related discipline + 11 years related experience; or Master’s + 9 years; or PhD + 5 years; or equivalent.
Required/Preferred Skills:
- Ability to manage multiple activities and deliver high-quality work within timelines.
- Strong regulatory framework knowledge and ability to develop innovative approaches.
- Clear verbal/written communication; ability to present to groups.
- Strong interpersonal skills; resolve differing views.
- Ability to manage teams and build collaborative stakeholder relationships.
- Analytical/problem-solving skills aligned to organizational goals.
- Integrity and trust-building leadership.
Job Complexity:
- Manage execution of multiple tasks; prioritize; proactively anticipate/resolve challenges; design/implement solutions considering broader impact.
Working Conditions:
- Travel ~20%.
- Oversee submission activity for the submission portfolio, manage submission forecast and staffing for upcoming submissions.
- Use in-depth knowledge of global regulatory submission requirements to guide Regulatory Affairs and cross-functional teams toward timely, high-quality filings.
- Identify areas impacting submission timelines, drive process efficiencies, and oversee/guide the Veeva RIM suite with best practices.
Essential Duties and Responsibilities:
- Oversee planning of regulatory submissions (INDs, NDAs, BLAs, supplemental applications, etc.) in electronic format.
- Ensure submission processes and best practices; clarify timelines and deliverables.
- Create/maintain global regulatory submission project plans; manage deliverable timelines; align roles/responsibilities; assess issues/risks/impacts from strategy/timeline changes; provide transparent status updates.
- Lead cross-functional team efforts to optimize submission processes.
- Develop submission planning best practices and implement major submission timelines.
- Partner with Vice President, Regulatory Operations on department best practices/ways of working.
- Identify IT solutions to enhance Regulatory Operations systems (e.g., project planning tools, Veeva RIM).
- Contribute to regulatory process documentation (SOPs/work instructions/guidelines) and departmental initiatives.
- Mentor Regulatory Operations team members on submission planning best practices.
- Review and interpret regulatory guidelines.
Qualifications:
- Bachelor’s degree in related discipline + 11 years related experience; or Master’s + 9 years; or PhD + 5 years; or equivalent.
Required/Preferred Skills:
- Ability to manage multiple activities and deliver high-quality work within timelines.
- Strong regulatory framework knowledge and ability to develop innovative approaches.
- Clear verbal/written communication; ability to present to groups.
- Strong interpersonal skills; resolve differing views.
- Ability to manage teams and build collaborative stakeholder relationships.
- Analytical/problem-solving skills aligned to organizational goals.
- Integrity and trust-building leadership.
Job Complexity:
- Manage execution of multiple tasks; prioritize; proactively anticipate/resolve challenges; design/implement solutions considering broader impact.
Working Conditions:
- Travel ~20%.