Regulatory Affairs Manager jobs in Ventura, CA

Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)

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Regulatory Affairs Manager
  • Advanced Bio-Logic Solutions Corp
  • Thousand Oaks, CA FULL_TIME
  • Description:
    Note:
    • 100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours
    • Need someone to can hit the ground running

    Ideal candidate: 
    • someone with a mixed background not just lab but manufacturing and process development.
    • This manager position within CMC will facilitate product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.

    Job Description:
    • Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations)
    • Create and maintain product regulatory history documents through IMR and appropriately archive all regulatory documents and agency communications.
    • Ensure compliance with submissions regulatory agencies
    • Coordinate QC of regulatory documentation (e.g. briefing packages)

    Basic Qualifications:
    • Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience.

    Top 3 Must Have Skill Sets:
    • Change Control evaluation or owner.
    • QA, Manufacturing or Operations background experience.
    • Process Development experience for biotech products.

    Day to Day Responsibilities:        
    • Assess change control records supporting ATO and ESQ areas
    • Support submissions with site related documents, as requested
    • Provide support for variation process

    PAY RATE : $60/Hr on W2.

    "This posting is for Contingent Worker, not an FTE"
  • 9 Days Ago

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Associate Regulatory Affairs - (JP9887)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Associate Regulatory Affairs - (JP9887) Location: Thousand Oaks, CA. Employment Type: Contract Business Unit: CMC Core Team A Duration: 1 years (with likely extensions) Notes: Onsite opport...
  • 18 Days Ago

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Regulatory Affairs Senior Associate
  • Advanced Bio-Logic Solutions Corp
  • Thousand Oaks, CA FULL_TIME
  • Top 3 Must Have Skill Sets: Knowledge of FDA Knowledge of Good Regulatory Practices/Good Clinical Practice Use of regulatory information management systems Day to Day Responsibilities: Coordination an...
  • 18 Days Ago

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Regulatory Affairs Associate
  • Actalent
  • Newbury, CA FULL_TIME
  • JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
  • 3 Days Ago

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Sr. Regulatory Affairs Associate
  • Actalent
  • Newbury, CA FULL_TIME
  • JOB SUMMARY: Responsible for coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, AU, Japan, MEA etc.) ESSENTIAL DUTIES:Independently plan, prepare, coordi...
  • 3 Days Ago

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Associate Regulatory Affairs
  • Advanced Bio-Logic Solutions Corp
  • Thousand Oaks, CA FULL_TIME
  • Top 3 Must Have Skill Sets: Familiarity with Global Clinical Trial Applications, Marketing Authorizations, Regulations, and Regulatory Guidance, including familiarity with US Certificate of Pharmaceut...
  • 9 Days Ago

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0 Regulatory Affairs Manager jobs found in Ventura, CA area

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Camarillo, CA
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Looking for Associate Regulatory Affairs-Contract- 100 % Remote.
  • Unisys Corporation
  • Newbury Park, CA
  • Unisys is an Information Technology and Business Consulting firm providing project-based solutions, software solutions a...
  • 4/26/2024 12:00:00 AM

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Thousand Oaks, CA
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Legal Admin Specialist (Estate & Gift Tax) (Estate Tax Technical Advisor) (TEMP NTE 1 YR MBE, MBP)
  • Department Of The Treasury
  • Santa Barbara, CA
  • Duties WHAT IS THE SMALL BUSINESS SELF EMPLOYED (SBSE)DIVISION? A description of the business units can be found at: htt...
  • 4/26/2024 12:00:00 AM

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Specialist Manufacturing, New Product Introductions
  • Amgen
  • Thousand Oaks, CA
  • **HOW MIGHT YOU DEFY IMAGINATION?** Youve earned your degree. How will you use that achievement to reach your goals? Do ...
  • 4/25/2024 12:00:00 AM

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Senior Planner
  • PDS Inc
  • Camarillo, CA
  • Job Description Job Description RESPONSIBILITIES: · Identifies variety of raw material and component requirements for pr...
  • 4/23/2024 12:00:00 AM

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Rev Cycle Operational Analyst
  • Luminous Technology Group
  • Ventura, CA
  • Company Description Job Description This position requires 2-3 days on-site per week in Ventura. Job Summary: The Revenu...
  • 4/22/2024 12:00:00 AM

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MANAGEMENT ANALYST (PUBLIC WORKS DEPARTMENT)
  • City of Santa Paula, CA
  • Santa Paula, CA
  • Salary : $78,769.60 - $95,784.00 Annually Location : Public Works- Santa Paula, CA Job Type: Full-Time - 9/80 Work Sched...
  • 4/22/2024 12:00:00 AM

Ventura is located northwest of Los Angeles on the California coast. The western portion of the city stretches north along the Ventura River and is characterized by a narrow valley with steeply sloped areas along both sides. The steep slopes of the Ventura foothills abut the northern portion of the community. Much of the eastern portion is on a relatively flat alluvial coastal plain lying along the western edge of the Oxnard Plain. The Santa Clara River forms the city's southerly boundary with the city limits reaching up to the beginning of the Santa Clara River Valley at the historic communit...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$147,678 to $208,308
Ventura, California area prices
were up 2.5% from a year ago

Regulatory Affairs Manager in Pittsfield, MA
The ideal candidate will have strong working knowledge of the agrochemical regulatory requirements.
December 24, 2019
Regulatory Affairs Manager in Stockton, CA
The world’s leading research-based pharmaceutical and healthcare companies is looking for a Regular Affairs Manager.
December 01, 2019
Regulatory Affairs Manager in Pierre, SD
Pharmaceutical companies, cosmetics manufacturers, food producers, and medical device suppliers hire regulatory affairs managers to make sure they adhere with all regulations.
February 01, 2020