Comforcehealth
Regulatory Affairs Associate I - Pharmaceutical - Analysts
Comforcehealth, Fremont, California, us, 94537
Regulatory Affairs Associate I - Pharmaceutical
Job ID: 985718Fremont, CaliforniaJob Type: ContractAdded - a day agoJob Description
A client of Innova Solutions is immediately hiring for a Regulatory Associate I
Position type:
Full-time ContractDuration:
20+ monthsLocation:
Fremont, California 94555 USAJob Responsibilities:Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined time schedule.Help determine regulatory strategies for manufacturing changes and regulatory activities.Aid in preparing Lifecycle Management like Annual Reports (Product, DMF).Coordinate and track workflows for regulatory submissions.Ensure regulatory submissions meet global standards.Participate in meetings and interact with project team members and sub-teams.Assist with and eventually lead licensing activities and required updates (Establishment Registration, California State License, State licensing).Support reporting requirements under the CARES Act.Provide support to Regulatory management as needed.Skills:PC literacy is required.Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project).Document Management Systems and Internet resources knowledge is expected.General knowledge and application of global regulations and cGMP requirements are necessary.Must be able to work independently and with appropriate supervision.Excellent organizational, interpersonal, and communication skills (oral and written) are required.Education:A Bachelor's degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master's degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required.Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Pay Range*: Pay Range: $34.00 - $36.00 per hour.*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits:
Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
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Job ID: 985718Fremont, CaliforniaJob Type: ContractAdded - a day agoJob Description
A client of Innova Solutions is immediately hiring for a Regulatory Associate I
Position type:
Full-time ContractDuration:
20+ monthsLocation:
Fremont, California 94555 USAJob Responsibilities:Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined time schedule.Help determine regulatory strategies for manufacturing changes and regulatory activities.Aid in preparing Lifecycle Management like Annual Reports (Product, DMF).Coordinate and track workflows for regulatory submissions.Ensure regulatory submissions meet global standards.Participate in meetings and interact with project team members and sub-teams.Assist with and eventually lead licensing activities and required updates (Establishment Registration, California State License, State licensing).Support reporting requirements under the CARES Act.Provide support to Regulatory management as needed.Skills:PC literacy is required.Proficiency in technology use, including MS Office skills (Outlook, Word, Excel, PowerPoint, MS Project).Document Management Systems and Internet resources knowledge is expected.General knowledge and application of global regulations and cGMP requirements are necessary.Must be able to work independently and with appropriate supervision.Excellent organizational, interpersonal, and communication skills (oral and written) are required.Education:A Bachelor's degree in a scientific field, preferably Chemistry or Pharmacy, with 1-3 years of experience, or a Master's degree in Regulatory Affairs with a minimum of 3 months of regulatory experience (internship) is required.Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.Pay Range*: Pay Range: $34.00 - $36.00 per hour.*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.Benefits:
Innova Solutions offers benefits (based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment.
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