Exel
Senior Director, Regulatory Affairs (Oncology)
Alameda, CA · Director
Stay score
odds of building a lasting career here
Sponsors, but it's cap-subject — you still face the weighted lottery (~61% per draw at Level IV). Good if you win; have a cap-exempt backup on your list.
Lottery odds assume a STEM candidate.
Personalize to your clock →H-1B wage level
the lottery is wage-weighted — each level is one more entry
$3,014 more — $251,014 — moves this role to Level IV and 4 lottery entries. That figure is inside the range the employer already advertised.
Based on the DOL prevailing wage for this occupation and worksite, a base salary of $251,014 would place this position at wage Level IV. That figure is within the posted range, and I'd like to target it. This role classifies under "Managers, All Other" for prevailing-wage purposes.
DOL prevailing wage, 2026-27 wage year · Managers, All Other (11-9199) · San Francisco-Oakland-Fremont, CA. Wage level is derived by USCIS from the offered wage, occupation and worksite; the occupation shown is inferred from the job title.
Employer immigration record
from this employer's Department of Labor filings
Files H-1B transfers
Sourced from Department of Labor LCA, PERM and prevailing-wage disclosure data. Employer matching is by name, so figures may be split across an employer's legal entities. Absence of a filing means none appears in our copy of the data, not that none exists.
Community outcomes
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About the role
- Ensures timely preparation of organized, consistent, and scientifically valid submissions.
- ESSENTIAL DUTIES AND RESPONSIBILITIES: - Interact directly with regulatory authorities. - Conduct effective and timely regulatory intelligence and research to provide guidance to study and asset teams.
- SUPERVISORY RESPONSIBILITIES: - Directly supervise employees.
Responsibilities
- Work with external vendors to plan, review, prepare, submit, and maintain CTAs in Europe, Asia, and other regions.
- Contribute to the implementation of processes and procedures, including developing and authoring internal work instructions and company SOPs.
- Lead multiple assets and/or studies as assigned.
- Communicates clearly and proactively with stakeholders to reduce regulatory risk and drive the implementation of appropriate mitigation strategies.
Requirements
- Bachelor's degree in related discipline and a minimum of fifteen years of related experience
- Master's degree in related discipline and a minimum of thirteen years of related experience
- PhD degree in related discipline and a minimum of twelve years of related experience
- It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.
Skills
- Establishes objectives for areas of responsibility and plans for successful outcomes, consistent with Regulatory Affairs strategy.
- Capable of proactively assessing workload, trends, tasks and priorities for cross-functional activity.
- Plans and executes multiple projects or activities, considering alternative methods and contingency plans to avoid potential issues.
- Travel approximately 20%
- Education/Experience:
- Bachelor's degree in related discipline and a minimum of fifteen years of related experience; or,
- Master's degree in related discipline and a minimum of thirteen years of related experience; or,
- PhD degree in related discipline and a minimum of twelve years of related experience; or,
- Equivalent combination of education and experience.
- Experience/The Ideal for Successful Entry into Job:
Compensation
- The base pay range for this position is $248,000 - $352,500 annually.
- The base pay range may take into account the candidate's geographic region, which will adjust the pay depending on the specific work location.
- Oversee the preparation and completion of regulatory submissions (electronic and paper), including investigational new drug applications, supplements and amendments, IND safety reports, annual reports/DSURs, other routine amendments, and new drug applications (NDA)/biologics license applications (BLA).
Benefits
- The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.
- Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan.
- Lead, author and evaluate documents submitted to regulatory health authorities to ensure they are complete, organized, of high quality, contain appropriate messaging and compliant with applicable regional regulations.
- Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements.
Company info
- Any resumes submitted through the website or directly by recruiters or staffing agencies that do not meet the above-mentioned criteria will be considered unsolicited and the company will not be responsible for any related fees.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.