Regulatory Affairs Strategy Manager (Oncology)

SUMMARY / JOB PURPOSE :

Responsible for managing and maintaining existing Investigational New Drug (IND), Clinical Trial Application (CTA), New Drug Application (NDA), and Biologics Licensing Application (BLA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications and submissions to regulatory agencies. 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.

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 Project Team Regulatory Representative in preparing routine IND, NDA and BLA submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
• Assist with developing and implementing 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 accomplish regulatory activities and submissions.
• Contribute to department initiatives.

SUPERVISORY RESPONSIBILITIES :

EDUCATION / EXPERIENCE / KNOWLEDGE & SKILLS :

Education / Experience :

Experience / The Ideal for Successful Entry into Job :

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JOB COMPLEXITY :

WORKING CONDITIONS :

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

Our compensation reflects the cost of labor across severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $124,500 - $177,000 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. The base pay offered will take into account the candidate's geographic region, job-related knowledge, skills, experience and internal equity, among other factors.

In addition to the base salary, as part of our Total Rewards program, Exelixis offers comprehensive employee benefits package, including a 401k plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts. Employees are also eligible for a discretionary annual bonus program, or if field sales staff, a sales-based incentive plan. Exelixis also offers employees the opportunity to purchase company stock, and receive long-term incentives, 15 accrued vacation days in their first year, 17 paid holidays including a company-wide winter shutdown in December, and up to 10 sick days throughout the calendar year.

DISCLAIMER

The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. 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.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.