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Regulatory Affairs Analyst Jobs in California

California Regulatory Affairs Analyst (Hybrid)
By California ISO At Folsom, CA, United States
Level of Education and Discipline:
Participate in paid on-call rotation and other job-related duties as assigned.
May perform related duties and activities as assigned.
Adheres to and supports the Core Values of the ISO.
Regulatory Affairs Analyst Jobs
By San Jose Water At San Jose, CA, United States
Required Knowledge Skills & Abilities
· Working knowledge of statistics, investments, budgeting, project management and computerized applications.
· The Regulatory Affairs Analyst requires substantial technical skill in finance, economics, and statistics.
· Utility rate-making methodologies and legal requirements.
· Excellent written and oral communication skills.
· A bachelor's degree or equivalent in finance, economics, accounting, engineering or a closely related field.
Regulatory Affairs Consultants Jobs
By Pharmatech Associates, a USP company At San Francisco, CA, United States
Develop, lead, and drive the execution of the regulatory strategy from pre-IND to launch, commercialization and product lifecycle management
Responsible for communicating business-related issues or opportunities to next management level
Plan and oversee activities in support of all regulatory submissions
Provide regulatory guidance to the Client across all areas of regulatory affairs throughout all stages from product development
Participate as part of internal regulatory team to define and execute the regulatory strategy
Support the preparation of briefing packages, and regulatory submission documents as needed , providing insight and expertise
Head Of Regulatory Affairs
By Life Science People At Torrance, CA, United States
Proven people management experience, with a track record of building and leading high-performing teams
Participate in the development and implementation of regulatory strategies to support product approvals, license maintenance, and lifecycle management
Collaborate with cross-functional teams to ensure that regulatory requirements are integrated into product development plans and timelines
Strong knowledge of FDA, EMA, and other global agencies' regulations related to CMC submissions for generics and NCEs
Excellent writing, communication, and interpersonal skills
Prepare and maintain CMC documentation for various applications, including NDAs, DMFs, CEPs, INDs, etc.
Regulatory Operations Analyst Jobs
By Airbnb At San Francisco, CA, United States
Previous project management experience is a plus
2 - 4 years experience in investigations and resolutions in a related industry or college degree
Excellent investigation skills and extreme attention to details
Experience working and coordinating efforts with multiple stakeholders
Quick learner, operates with urgency and curiosity, and evolves your knowledge as new information becomes available
Strong verbal and written communication skills
Regulatory Affairs Associate Jobs
By Intellectt Inc At Alameda County, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Recent experience with Class III implantable medical devices
Knowledge of FDA PMA guidance documents and CFR regulations.
Relies on extensive experience and judgment to plan and accomplish goals.
Typically reports to a manager or head of a unit/department.
knowledge of FDA PMA guidance documents and CFR regulations.
Vp, Regulatory Affairs Strategy
By Exelixis, Inc. At , Alameda, 94502, Ca $313,000 - $363,000 a year
Monitor current and proposed regulatory issues and trends and advise management on events of significance for Exelixis’ business interests.
Equivalent combination of education and experience.
Deep knowledge and understanding of the drug development process and regulatory requirements and environment
Strong interpersonal skills and the ability to skillfully and appropriately manage, develop and mentor personnel in a matrix environment
Provide Regulatory assessment to due diligence teams in terms of risks, requirements, and opportunities associated with potential in-licensed assets
Bachelor’s degree in related discipline and a minimum of twenty-one years of related experience; or,
Head Of Regulatory Affairs - Igt-D
By Philips At , San Diego, Ca
Extensive experience and knowledge required of global medical device regulations, requirements, and standards;
Leading strategic AOP management to optimize revenue
10 years of people management – with a strong track-record in successfully leading a Regulatory Affairs team
Experienced in strategic relationships with external stakeholders (e.g. Notified Bodies, FDA, Competent Authorities);
*Montana employees are currently excluded from this requirement at this time.
In return, we offer you
Regulatory Affairs Associate Jobs
By Select Source International At Alameda, CA, United States
Experience with global regulations and/or CE marking beneficial.
Relies on experience and judgment to plan and accomplish goals. Performs a variety of tasks.
Typically reports to a manager.
May lead and direct the work of others.
A wide degree of creativity and latitude is expected.
Job Title: Regulatory Affairs Associate
Program/Policy Analyst, Sr. (Medi-Cal Regulatory Affairs)
By CalOptima At Orange, CA, United States
Assists in the management of CalOptima Health’s daily relationship with the DHCS for CalOptima Health’s Medi-Cal program.
Assists in the management of CalOptima Health’s daily relationship with the DMHC.
Maintains open lines of communication to ensure the ongoing trust and confidence of regulators in the program and management.
3 years of experience in government, public or government affairs role in health care compliance or health plan requirements required.
Assists the team in carrying out department responsibilities and collaborates with others to support short- and long-term goals/priorities for the department.
Experience working with regulatory agencies in California.
Executive Director, Regulatory Affairs Strategy
By Neurocrine Biosciences At San Diego, CA, United States
Provides strategic guidance on global regulatory requirements to management and project teams
Detailed knowledge of FDA/EMA/ICH regulations and guidance for global drug development, preparation and management of IND/CTA/MAA/BLA/NDA applications
Regulatory experience and detailed knowledge outside the US (Japan and/or EU) is preferred
Manages preparation of all regulatory submissions (IND/CTA/MAA/BLA/NDA)
Master's degree preferred and 15+ years of related experience, OR
PhD and 12+ years of related experience OR
Regulatory Affairs Specialist 1 Jobs
By Hologic At , San Diego, Ca $65,000 - $89,600 a year
Understanding of product life cycle process, design control and/or risk management.
Participate on product development core teams as regulatory representative and provide guidance on global regulatory requirements for new/existing products.
Interpret and clearly explain regulatory requirements and standards for IVDs and medical device products to cross-functional stakeholders.
Prepare/manage internal procedures for continuous process improvement. Provide guidance on new or revised procedures and policies (as assigned).
Bachelors with 1 years of experience or Masters with 0 year of industry experience or equivalent
Technical knowledge including (but not limited to) Biomedical/Life Sciences/Engineering/Clinical.
Global Regulatory Affairs Coordinator
By CooperVision At , San Ramon, Ca $62,285 - $83,046 a year
Interfaces with management and department.
Complies with management direction. Seeks assistance from supervisor in identifying and reporting problems or concerns relating to job functions.
Conducts self in a professional manner with colleagues, management, customers, and others. Models the corporate values.
Maintains contracts and invoice coordination with respect to Regulatory requirements.
No significant travel. Occasional requirements to attend offsite meetings.
Have attention to detail with organizational skills
Sr. Manager Regulatory Affairs
By Wimmer Solutions At Santa Monica, CA, United States
Education, Knowledge, Skills, & Abilities
Eight (8) or more years of experience in the regulatory function on cosmetic/personal care, skin care, pharmaceutical or manufacturing industry experience.
Previous experience with pharmaceutical (Rx/OTC) manufacturing and skin care is a plus.
Bachelor’s degree in Chemistry, Applied Science, or related field, required.
Master's degree in Chemistry, Biology, Toxicology, Pharmacology or equivalent preferred.
Demonstrated ability to work independently and practically, handle multiple tasks simultaneously, prioritize, negotiate and meet critical timelines.
Staff Software Regulatory Affairs Analyst (Remote)
By BD At , San Diego, 92130, Ca
Direct experience with Medical Device Software regulations IEC 62304 / 82304, IEC 60601.
5+ year's validated experience with regulated medical device development.
Validated understanding of QMS, demonstrating experience in supporting QMS process implementation using methodologies that promote compliant and agile software development practices.
Minimum of 5 years’ validated experience working with US 510(k)/PMA and CE Tech Files including software-driven medical devices and related products.
Knowledge of hardware-based device development, compliance testing, and documentation (i.e., traceability, integration, verification) a plus.
Certifications (RAC, CQA, CQM, etc.) preferred.
Sr Associate Regulatory Affairs - Cmc - (Open To Remote)
By Amgen At , Los Angeles, Ca $83,292 - $104,433 a year
Developed project management and organizational skills
Document and archive CMC submissions and related communications in the document management system
Regulatory CMC specific knowledge and experience
Lead the organization and preparation of the CMC sections of global annual notifications to meet regulatory requirements
Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development
Strong and effective oral and written communication skills
Regulatory Strategist, Global Regulatory Affairs
By Kite Pharma At Santa Monica, CA, United States
Good project management skills, as evidenced by ability to manage multiple assignments simultaneously without compromise to timelines or quality.
Knowledgeable with the drug development process, cell therapy industry, and Regulatory practices; eCTD submission experience highly preferred
Helps expedite and improve regulatory administrative activities by training and advising new or less experienced colleagues.
Ensures own work complies with established practices, policies and processes, and any regulatory or other requirements.
Master’s and 2+ years of relevant experience OR
Bachelor’s and 4+ years of relevant experience OR
Regulatory Affairs Associate Jobs
By Intellectt Inc At Santa Clara, CA, United States
May require an advanced degree and 5-8 years of direct experience in the field.
Knowledge of FDA PMA guidance documents and CFR regulations.
Monitoring changing regulations (emerging regulatory issues, trends) in rest of the world geographies and translating regulatory requirements into the quality system.
Driving implementation of new international regulatory requirements, ensuring procedures are current and regulatory requirements and guidelines are met.
Review/approval of engineering study protocols/reports and validation study protocols/reports.
Review and approval of manufacturing changes for Class III implantable medical devices.
Counsel, Privacy & Regulatory Affairs
By TikTok At San Jose, CA, United States

Responsibilities Company Introduction TikTok is the leading destination for short-form mobile video. Our mission is to inspire creativity and bring joy. TikTok has global offices including Los ...

Head Of Regulatory Affairs
By Compass Life Sciences At San Francisco Bay Area, United States
8+ years of regulatory experience in the CRO, pharmaceutical, or biotech industry.
Experience working in a small biotech environment is highly preferred
Subject matter expert knowledge of US regulations
Bachelor’s or more advanced degree in a scientific discipline
You should be able to demonstrate the following;
+44 (0) 2394 311075, + (1) 98 444 9942

Are you looking for a challenging and rewarding career in Regulatory Affairs? We are looking for a Regulatory Affairs Analyst to join our team and help us ensure compliance with all applicable regulations. You will be responsible for researching and analyzing regulatory requirements, preparing regulatory submissions, and providing guidance to internal stakeholders. If you have a passion for regulatory compliance and are looking for an opportunity to make a difference, this could be the perfect job for you!

A Regulatory Affairs Analyst is responsible for ensuring that a company’s products and services comply with all applicable laws and regulations. They are responsible for researching, interpreting, and communicating regulatory requirements to internal stakeholders, as well as providing guidance on regulatory compliance.

What is Regulatory Affairs Analyst Job Skills Required?

• Knowledge of applicable laws and regulations
• Excellent research and analytical skills
• Strong communication and interpersonal skills
• Ability to work independently and as part of a team
• Ability to work under pressure and meet deadlines
• Proficiency in Microsoft Office Suite

What is Regulatory Affairs Analyst Job Qualifications?

• Bachelor’s degree in a related field such as law, public policy, or business
• Relevant experience in regulatory affairs
• Professional certification in regulatory affairs (e.g. Regulatory Affairs Professional Society (RAPS) certification)

What is Regulatory Affairs Analyst Job Knowledge?

• Knowledge of applicable laws and regulations
• Understanding of the regulatory environment and its impact on business operations
• Knowledge of the product development process
• Knowledge of the regulatory submission process

What is Regulatory Affairs Analyst Job Experience?

• Previous experience in regulatory affairs
• Experience in a related field such as law, public policy, or business

What is Regulatory Affairs Analyst Job Responsibilities?

• Research and interpret applicable laws and regulations
• Develop and maintain regulatory compliance strategies
• Prepare and submit regulatory documents
• Monitor regulatory changes and updates
• Provide guidance and advice on regulatory compliance
• Liaise with internal and external stakeholders
• Track and report on regulatory compliance activities