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Collabera
Alameda, CA, United States
Description Home Search Jobs Job Description Regulatory Affairs Associate Contract: Alameda, California, US Salary: $55.00 Per Hour Job Code: 335424 End Date: 2024-04-10 Days Left: 26 days, 3 hours left Apply To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-
Job Source: CollaberaCollabera
Alameda, CA, United States
Description Home Search Jobs Job Description Regulatory Affairs Associate Contract: Alameda, California, US Salary: $55.00 Per Hour Job Code: 335424 End Date: 2024-06-05 Days Left: 1 days, 3 hours left Apply To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-
Job Source: CollaberaIntellectt Inc
Alameda, CA, United States
Hello, I Hope you are doing great. This is Bhanu from Intellectt INC; we’ve got an important role Regulatory Affairs Associate - Alameda, CA with one of our prestigious clients. Interested candidates can please send your updated resume at [email protected] Role: Regulatory Affairs Associate Location: Alameda, CA Duration: 12 Months S
Job Source: Intellectt IncAlector
South San Francisco, CA, United States
Our mission is to develop therapies that empower the immune system to combat neurodegeneration and our team is focused on developing treatments for some of the most challenging diseases facing our society. We are supported in this mission by experienced and accomplished scientists and clinicians, a novel portfolio of programs, leading healthcare in
Job Source: AlectorCytokinetics
South San Francisco, CA, United States
Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mecha
Job Source: Cytokinetics4D Molecular Therapeutics
Emeryville, CA, United States
Attention recruitment agencies: All agency inquiries are vetted through 4DMT's internal Talent Acquisition team. No unsolicited resumes will be accepted. Agencies must be expressly engaged by the 4DMT Talent Acquisition team on any requisition. Agencies reaching out directly to hiring managers will not be tolerated and doing so may impact your abi
Job Source: 4D Molecular TherapeuticsThe Fountain Group
San Mateo, CA, United States
Overview: Prefers the candidate to be local in the Bay Area BUT will consider qualified candidates with Pharma Regulatory CMC experience in the Pacific time zone ONLY. Responsibilities Responsible for the preparation of moderately complex regulatory submissions which require interaction with departments outside of Regulatory Affairs CMC for invest
Job Source: The Fountain GroupInnova Solutions
San Rafael, CA, United States
Innova Solutions is immediately hiring for an Associate Director, Regulatory Affairs Position type: Full time Contract Duration: 6 months Location: San Rafael, CA As a Associate Director, Regulatory Affairs , you will: Job Description: Regulatory Strategy Development Lead the development, integration, execution and maintenance of the glo
Job Source: Innova SolutionsAlameda, CA, United States
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:
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 exUS 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.
Supervisory Responsibilities:
No direct supervision in role
EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:
Education/Experience:
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.
Experience/The Ideal for Successful Entry into Job:
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.
Knowledge/Skills:
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.
JOB COMPLEXITY:
Working Conditions:
Environment: primarily working indoors, performing clerical work
Notice to Recruiters/Staffing Agencies
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 severalU.S. geographic markets, and we pay differently based on those defined markets. The base pay range for this positionis $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.
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Email Alert for Regulatory Affairs Associate jobs in Alameda, CA, United States
ⓘ There was an unexpected error processing your request.
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