Exel
Assoc Regulatory Affairs Strategy Director (Oncology)
Alameda, CA · Director
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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
This range already reaches Level IV — the maximum four lottery entries.
DOL prevailing wage, 2026-27 wage year · Compliance Officers (13-1041) · 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.
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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.
- Provides timely and appropriate information updates.
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 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 eleven years of related experience
- Master's degree in related discipline and a minimum of nine years of related experience
- PhD degree in related discipline and a minimum of five 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
- Capable of managing the execution of multiple tasks.
- Ensures appropriate prioritization and execution for area of responsibility.
- Proactively anticipates, prioritizes and resolves task-related challenges.
- Travel approximately 10%
- Education/Experience:
- Bachelor's degree in related discipline and a minimum of eleven years of related experience; or,
- Master's degree in related discipline and a minimum of nine years of related experience; or,
- PhD degree in related discipline and a minimum of five 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 $195,000 - $277,500 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.
- Responsible for the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.