Regulatory Affairs Specialist
3 weeks ago
Job 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 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).
- Provide support to Regulatory management as needed.
- 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.
Requirements:
- 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).
What We Offer:
- Medical, Dental & Vision Benefits
- 401K Retirement Saving Plan
- Life & Disability Insurance
- Direct Deposit & weekly ePayroll
- 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.
-
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 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
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 Specialist
1 month ago
Fremont, California, United States Yoh Full timeRegulatory Affairs Associate IYoh, a leading staffing company, is seeking a highly skilled Regulatory Affairs Associate I 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 standards.Key Responsibilities:Assist in preparing responses to global information requests and...
-
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 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 Staffing Full timeJob OverviewWe are seeking a highly skilled Regulatory Affairs Associate to join our team. The successful candidate will be responsible for assisting in the preparation of responses to global information requests and related maintenance documentation.Key ResponsibilitiesAssist in preparing responses to global information requests and related maintenance...
-
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 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...
-
Fremont, California, United States Abbott Full timeThe OpportunityThis Senior International Regulatory Operations Specialist will join our team at Abbott's Alameda, CA location in the Diabetes Care Division. We're revolutionizing the way people manage their diabetes with innovative products that provide accurate data to drive better-informed decisions.As an individual contributor, the Senior Specialist will...
-
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...
-
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,...
-
Administrative Operations Specialist
3 weeks ago
Fremont, California, United States Bayside Solutions Full timeJob Summary:We are seeking a highly skilled Administrative Operations Specialist to join our team at Bayside Solutions, Inc.About the Role:The successful candidate will be responsible for managing and tracking Medical Affairs activities, executing agreements with Medical Affair's suppliers, and ensuring compliance with internal policies throughout the...
-
Quality Assurance Specialist
4 weeks ago
Fremont, California, United States Ardelyx Full timeAbout the RoleArdelyx is a leading commercial biopharmaceutical company dedicated to discovering, developing, and commercializing innovative first-in-class medicines that address significant unmet medical needs. As a Quality Assurance Specialist III/IV, you will play a critical role in ensuring the quality and compliance of our products and processes.Key...
-
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...
-
CSV Validation Specialist
1 month ago
Fremont, California, United States Katalyst HealthCares & Life Sciences Full timeJob Title: CSV Validation SpecialistAt Katalyst HealthCares & Life Sciences, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will be responsible for ensuring the accuracy and reliability of our computer systems and software.Responsibilities:Develop and implement CSV protocols and procedures to...
-
RN Clinical Regulatory Compliance Specialist
4 weeks ago
Fremont, California, United States Spectrum Health Full timeAbout the RoleThis is a corporate position with primary work supporting Clinical Compliance, Accreditation and Regulatory Compliance at Corewell Health Ludington and Gerber Hospitals.About Corewell HealthWe are a health system committed to providing a safe environment for our team members, patients, visitors, and community. We require a drug-free workplace...
-
CSV Validation Specialist
4 weeks ago
Fremont, California, United States Katalyst HealthCares & Life Sciences Full timeJob Title: CSV Validation SpecialistAt Katalyst HealthCares & Life Sciences, we are seeking a highly skilled CSV Validation Specialist to join our team. As a CSV Validation Specialist, you will play a critical role in ensuring the validation of computerized systems that support our pharmaceutical manufacturing operations.Responsibilities:Develop and execute...
-
Quality Assurance Specialist
4 weeks ago
Fremont, California, United States Asahi Kasei Full timeJob Title: Quality Assurance SpecialistWe are seeking a highly skilled Quality Assurance Specialist to join our team at Asahi Kasei. The successful candidate will be responsible for ensuring that our products and processes meet established quality standards and regulatory requirements.Key Responsibilities:Conduct audits and implement quality control...