Exel
Senior Director, Regulatory Affairs (Oncology)
Alameda, CA · Director
Sponsorship not specified$248k-$353kDetected 7 days ago
HRFDA RegulatoryResearchCollaborationRegulatory Affairs
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
- Responsible for driving the development and implementation of global regulatory strategies that align with asset and corporate goals as well as health authority requirements.
- 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.
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.