- Review clinical site regulatory documents to provide Regulatory approval to ship investigational product.
- Regulatory document archival into electronic system
- Track safety reports and coordinate submissions to US INDs.
- Assist Project Team Regulatory Representative in preparing routine IND submissions and ex-US clinical trial applications, tracking submission progress, and archiving regulatory submissions and correspondence.
- Manage portfolio timelines in collaboration with Regulatory Operations and Regulatory Affairs staff to effectively enable a robust regulatory submissions calendar.
- Facilitate the internal review and approval process for regulatory submissions.
- No direct supervision in role
- AA degree in related discipline and a minimum of three years of related experience; or,
- BS/BA degree in related discipline and a minimum of one year of related experience; or,
- MS/MA degree in related discipline and related experience; or,
- Equivalent combination of education and experience.
- Typically requires a minimum of two years of related experience and/or combination of experience and education/training in regulatory affairs.
- Knowledge of US and ex-US regulations and guidelines.
- Organizes and prioritizes numerous tasks and completes them under time constraints.
- Frequently applies technical standards, principles, theories, concepts, and techniques.
- Performs a variety of tasks with a wide degree of creativity and latitude.
- Resolves a wide range of issues in creative ways.
- Applies strong communication skills.
- Has good general knowledge of other related disciplines.
- Environment: primarily working indoors, performing clerical work
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Regulatory Affairs Associate - Alameda, United States - Exelixis
Description
SUMMARY/JOB PURPOSE:Responsible for managing and maintaining existing investigational new drug (IND) and clinical trial application (CTA) submissions and preparing amendments in compliance with guidelines and regulations. Coordinates, compiles, and tracks product applications to regulatory agencies.
Essential Duties And Responsibilities:
Education/Experience:
Working Conditions:
Recruiters and staffing agencies should not contact Exelixis, Inc. through this page. We require that all recruiters and staffing agencies have a signed contract on file and be assigned a specific search by our human resources department. 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.
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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 several U.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this position is $70,000 - $99,000 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.
