Regulatory Affairs Strategy Manager (Oncology)
Exelixis
1 month ago
Remote friendly (Alameda, CA)
United States
$124,500 - $177,000 USD yearly
Corporate Functions
Role Purpose
- Manage and maintain existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions, and prepare amendments in compliance with guidelines and regulations.
- Coordinate, compile, and track product applications and submissions to regulatory agencies.
- Assist senior regulatory leaders with development of documents for designations, health authority programs/requirements, health authority responses, and global regulatory planning.
Essential Duties and Responsibilities
- Review clinical site regulatory documents to provide regulatory approval to ship investigational product.
- Track safety reports and coordinate submissions to US INDs.
- Assist the Project Team Regulatory Representative with routine IND, NDA, and BLA submissions and ex-US clinical trial applications; track submission progress and archive regulatory submissions and correspondence.
- Develop and implement strategies to ensure compliance with HA requirements.
- Respond to requests for information from regulatory bodies.
- Serve as liaison with FDA.
- Work collaboratively with consultants and contractors to complete regulatory activities and submissions.
- Contribute to department initiatives.
Qualifications
- Bachelor’s degree in a related discipline with 7+ years of related experience, or
- Master’s degree with 5+ years of related experience, or
- PhD in a related discipline, or
- Equivalent combination of education and experience.
Required Skills/Competencies
- Ability to work independently and with others; deliver high-quality work within established timelines.
- Ability to gather, maintain, and apply regulatory knowledge for routine work.
- Clear verbal and written communication; provide timely updates to management and colleagues.
- Strong interpersonal skills and ability to reach agreed resolutions.
- Collaborative, analytical problem-solving aligned with organizational objectives.
- Manage and execute own work with integrity and trust-building.
Job Complexity
- Follow predefined procedures; identify task challenges and prioritize.
- Identify and escalate issues with broader impact; implement solutions.
Working Conditions
- Travel approximately 10%.
Benefits (as stated)
- 401k with company contributions; group medical, dental, and vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales-based incentive for field sales); opportunity to purchase company stock; long-term incentives; 15 vacation days (first year); 17 paid holidays (including winter shutdown in December); up to 10 sick days/year.
- Manage and maintain existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions, and prepare amendments in compliance with guidelines and regulations.
- Coordinate, compile, and track product applications and submissions to regulatory agencies.
- Assist senior regulatory leaders with development of documents for designations, health authority programs/requirements, health authority responses, and global regulatory planning.
Essential Duties and Responsibilities
- Review clinical site regulatory documents to provide regulatory approval to ship investigational product.
- Track safety reports and coordinate submissions to US INDs.
- Assist the Project Team Regulatory Representative with routine IND, NDA, and BLA submissions and ex-US clinical trial applications; track submission progress and archive regulatory submissions and correspondence.
- Develop and implement strategies to ensure compliance with HA requirements.
- Respond to requests for information from regulatory bodies.
- Serve as liaison with FDA.
- Work collaboratively with consultants and contractors to complete regulatory activities and submissions.
- Contribute to department initiatives.
Qualifications
- Bachelor’s degree in a related discipline with 7+ years of related experience, or
- Master’s degree with 5+ years of related experience, or
- PhD in a related discipline, or
- Equivalent combination of education and experience.
Required Skills/Competencies
- Ability to work independently and with others; deliver high-quality work within established timelines.
- Ability to gather, maintain, and apply regulatory knowledge for routine work.
- Clear verbal and written communication; provide timely updates to management and colleagues.
- Strong interpersonal skills and ability to reach agreed resolutions.
- Collaborative, analytical problem-solving aligned with organizational objectives.
- Manage and execute own work with integrity and trust-building.
Job Complexity
- Follow predefined procedures; identify task challenges and prioritize.
- Identify and escalate issues with broader impact; implement solutions.
Working Conditions
- Travel approximately 10%.
Benefits (as stated)
- 401k with company contributions; group medical, dental, and vision; life and disability insurance; flexible spending accounts; discretionary annual bonus (or sales-based incentive for field sales); opportunity to purchase company stock; long-term incentives; 15 vacation days (first year); 17 paid holidays (including winter shutdown in December); up to 10 sick days/year.