Exel
Regulatory Affairs Strategy Manager (Oncology)
Alameda, CA
Sponsorship not specified$126k-$180kDetected 1 day ago
FDA RegulatoryCommunicationCollaborationRegulatory Affairs
About the role
- Coordinates, compiles, and tracks product applications and submissions to regulatory agencies.
- Experience/The Ideal for Successful Entry into Job: Knowledge/Skills: - Works independently and with others to contribute to plans, complete tasks and achieve results within established timelines.
- The base pay range for this position is $126,000 - $179,500 annually.
Responsibilities
- Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
- Assist with developing and implementing strategies to ensure compliance with HA requirements.
Requirements
- Bachelor's degree in related discipline and a minimum of seven years of related experience
- Master's degree in related discipline and a minimum of five years of related experience
- PhD degree in related discipline
- 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
- Good interpersonal skills, understanding of differing views; participates in reaching an agreed upon resolution.
- Capable of following predefined procedures for specific tasks.
- Capable of identifying task-related challenges and prioritizing activity accordingly.
- Identifies and escalates issues that may have a broader impact.
- Implements solutions to address any task-related challenges.
- Travel approximately 10%
- Education/Experience:
- Bachelor's degree in related discipline and a minimum of seven years of related experience; or,
Compensation
- The base pay range for this position is $126,000 - $179,500 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.
Benefits
- Assists senior regulatory leaders with the development of documents to support desigations and other health authority programs and requirements, health authority responses, and global regulatory planning.
- 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.
This listing is sourced directly from Exel's careers page and normalized into a canonical job model.