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Regulatory Affairs Associate - II

Job ID: 23-00944
Intelliswift Software Inc. conceptualizes, builds, and supports the world's most amazing technology products and solutions. Our team of rich experts from diverse backgrounds contributes to making Intelliswift one of the most reliable partners in IT and Talent solutions. We specialize in delivering world-class Digital Product Engineering, Data Management and Analytics, and Staffing Solutions services to Fortune companies, SMBs, ISVs, and fast-growing startups.
 
Please review the job description below and advise if you would like to explore it further. We may have other jobs available as well which we can discuss once we connect.
 
Job Title: Senior Associate - Regulatory Affairs CMC
Duration: 12 months
Location: Foster City, CA
Pay Range: $60 - $ 66.66/hour
 
Actual Title: Senior Associate - Regulatory Affairs CMC

Full time/on site role that 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. All other candidates submitted outside of the West Coast will be rejected by the PMO **

Specific Job Responsibilities
Responsible for the preparation of moderately complex regulatory submissions which require interaction
with departments outside of Regulatory Affairs CMC for investigational products for US, Asia and LATAM
and marketed products for US in line with ICH requirements, regional requirements and scientific and
company policies and procedures.
Responsible for routine clinical and commercial labeling approvals and changes, protocol reviews, drug
listing review and ensure ensuring product packaging and associated information is updated and
maintained in accordance with the product license.
Develop and maintain knowledge of regulatory requirements independently and with line manager.
Assess change controls for regional regulatory impact and record assessment using a variety of internal
systems.
Contribute to local process improvements, which have an impact on the working of the RA CMC function
or other departments.
Work cross-functionally within a matrixed organization.
Primarily plans, schedules and arranges own activities in alignment with project goals and deadlines.
Must be capable of leading a small team in preparation of regional submissions.
Must work well under deadlines and have excellent attention to detail. Strong computer and organizational
skills required. Work is performed under limited direction of a senior Regulatory Affairs professional.
Excellent verbal and written communication skills and interpersonal skills are required.

Education & Experience
A Bachelor’s Degree with a minimum of 6+ years of relevant training or industry experience preferably in a
GMP environment, OR a Master’s Degree with a minimum of 4+ years of relevant training or industry
experience preferably in a GMP environment.
Preferred
Degree in a relevant scientific field.
Relevant Regulatory CMC submission experience.
Regulatory Affairs Certification (RAC).
 
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Intelliswift is committed to fair and equitable compensation practices. The range provided for this position is determined by various factors including, but not limited to, relevant work experience, skills, certifications, and location. Intelliswift offers medical insurance, dental insurance, vision insurance, supplemental life and AD&D insurance, and any other benefits per state law.
 
Equal Employment Opportunity Statement
Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.
Americans with Disabilities Act (ADA)
If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department
Other Employment Statements
Intelliswift participates in the E-Verify program.
 

For information on Intelliswift Software, Inc., visit our website at www.intelliswift.com.
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