Regulatory Affairs Associate I
1 month ago
Duration: 08 Months Contract (Possible Extension)
Description:
- Assist in preparing responses to global information requests and related maintenance documentation (amendments, supplements, annual reports, safety reports, etc.) within a defined 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, 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.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
Recruiter Details:
Name: Kanika
Email: kanika.d@ustechsolutionsinc.com
Internal Id: 24-23328
-
Regulatory Affairs Specialist
4 weeks ago
Fremont, California, United States Yoh Full timeRegulatory Affairs Associate IYoh is seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team. As a Regulatory Affairs Associate I, you will assist in preparing responses to global information requests and related maintenance documentation, determine regulatory strategies for manufacturing changes and regulatory...
-
Regulatory Affairs Associate
1 month ago
Fremont, United States Meet Full timeRegulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...
-
Regulatory Affairs Specialist
3 weeks ago
Fremont, California, United States Yoh Full timeRegulatory Affairs Associate I Job DescriptionWe are seeking a highly skilled Regulatory Affairs Associate I to join our team at Yoh. As a key member of our regulatory team, you will be responsible for assisting in preparing responses to global information requests and related maintenance documentation.Key Responsibilities:Assist in preparing responses to...
-
Regulatory Affairs Specialist
4 weeks ago
Fremont, California, United States US Tech Solutions Full timeJob Title: Regulatory Affairs Associate IDuration: 08 Months Contract (Possible Extension)We are seeking a highly motivated and detail-oriented Regulatory Affairs Associate I to join our team at US Tech Solutions. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and standards.Assist in...
-
Regulatory Affairs Associate I
3 weeks ago
Fremont, CA, United States Yoh Full timeRegulatory Affairs Associate I External ID # Fremont, CA - ON SITE 22 month W2 contract (with potential to extend or transition to perm) Pay rate: $30-35/hour - Depending on Education and Experience Summary: Shift: 1st Shift: Mon-Fri, 8:00AM-5:00PM Responsibilities:Assist in preparing responses to global information requests and related maintenance...
-
Regulatory Affairs Associate
2 weeks ago
Fremont, CA, United States Meet Full timeRegulatory Affairs AssociateLocation: Fremont, CAOur innovative client is seeking a Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and...
-
Regulatory Affairs Specialist
3 weeks ago
Fremont, California, United States Meet Full timeRegulatory Affairs AssociateJob SummaryMeet is seeking a highly skilled Regulatory Affairs Associate to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key ResponsibilitiesPrepare and coordinate...
-
Regulatory Affairs Specialist
3 weeks ago
Fremont, California, United States Yoh Full timeJob Summary:Yoh is seeking a highly skilled Regulatory Affairs/Quality Associate to join our team. As a key member of our regulatory team, you will play a critical role in ensuring compliance with global regulations and cGMP requirements.Key Responsibilities:Help determine regulatory strategies for manufacturing changes and regulatory activities.Coordinate...
-
Regulatory Affairs Specialist
3 weeks ago
Fremont, California, United States eTeam Full timeJob Title: Regulatory Affairs SpecialistAt eTeam, we are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for assisting in preparing responses to global information requests and related maintenance documentation. Your duties will include determining regulatory strategies...
-
Regulatory Affairs Director
4 weeks ago
Fremont, California, United States Scribe Therapeutics Full timeJob Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is passionate about developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...
-
Regulatory Affairs Associate I
2 days ago
Fremont, CA, United States Joulé Full timeJob Title: Regulatory Associate I Find out more about this role by reading the information below, then apply to be considered. Location: Fremont, CA Hours/Schedule: Full-time Compensation: $25-33/hr Overview Prepare and coordinate the compilation and/or submission of documents to regulatory agencies in support of maintenance and compliance requirements...
-
Regulatory Affairs Director
4 weeks ago
Fremont, California, United States Scribe Therapeutics Full timeJob DescriptionScribe Therapeutics is a molecular engineering company focused on creating innovative in vivo therapies that address the root causes of diseases. Our team of experts, including CRISPR inventors and leading molecular engineers, is dedicated to developing custom engineered enzymes and delivery modalities as part of our proprietary CRISPR by...
-
Principal Regulatory Affairs Specialist
4 weeks ago
Fremont, California, United States Abbott Full timeThe OpportunityWe are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team in the Diabetes Care Division at Abbott. As a key member of our regulatory team, you will play a critical role in ensuring the successful introduction of new products in the US market.Our team is responsible for developing and implementing regulatory...
-
Regulatory Science Specialist
3 weeks ago
Fremont, California, United States iMPact Business Group Full timeJob OverviewWe are seeking a highly skilled Regulatory Science Technician to join our team at iMPact Business Group. As a key member of our team, you will be responsible for assisting in the development and validation of testing methodologies used to control raw materials, production intermediates, and final products.Key Responsibilities:Develop and validate...
-
Staff Nurse I
4 weeks ago
Fremont, California, United States Washington Hospital Full timeJob SummaryThe Staff Nurse I is a new graduate professional caregiver who assumes responsibility and accountability for a group of patients for a designated time frame. This role provides fiscally responsible care to these patients via therapeutic use of self, the nursing process, the environment/instrumentation, and other health care team members following...
-
Manufacturing Associate I
4 weeks ago
Fremont, California, United States Fladger Assoc. Inc. Full timeJob DescriptionFladger Assoc. Inc. is seeking a skilled Manufacturing Associate I to join our team in Fremont, CA. This is a contract position with a duration of 6-24 months and a negotiable rate.Responsibilities:Prepare various media and stock solutions to support cell culture operations.Follow SOPs to perform routine cleaning activities and maintain...
-
Logistics Associate I
3 weeks ago
Fremont, United States Compunnel, Inc. Full timeJob DescriptionJob DescriptionJob Summary:The Logistics Associate I is responsible for accurately picking, packing, staging, scaling, and loading customer orders for both internal and external movement. This role includes maintaining supplies, ensuring a clean work environment, and actively participating in training and audits to uphold company standards.Key...
-
Quality Assurance Engineer
4 weeks ago
Fremont, United States GForce Life Sciences Full timeKey Responsibilities: Conduct routine and non-routine biochemical and chemical analysis of raw materials, in-process items, and finished products, adhering to established operating procedures. Compile and document test data, participate in stability program testing, and contribute to formulation studies. Calibrate, maintain, and troubleshoot lab and...
-
Senior Quality Assurance Specialist
2 weeks ago
Fremont, California, United States GForce Life Sciences Full timeKey Responsibilities:Execute routine and non-routine biochemical and chemical analysis of raw materials, in-process items, and finished products, adhering to established operating procedures, ensuring consistency and accuracy in testing practices.Compile and document test data, participate in stability program testing, and contribute to formulation studies,...
-
Quality Assurance Specialist
3 weeks ago
Fremont, California, United States Integrated Resources Full timeJob Summary:Integrated Resources is seeking a highly skilled Quality Assurance Associate to join our team. As a key member of our quality assurance team, you will be responsible for conducting routine and non-routine analysis of raw materials, in-process items, and finished products according to established operating procedures.Key Responsibilities:Conducts...