Regulatory Affairs Director jobs in Ventura, CA

Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)

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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 opportunity - Thousand Oaks, CA
    Posting Date:  03/09/2022

    3 Key Consulting is hiring an Associate Regulatory Affairs CMC for a consulting engagement with our direct client, a leading global biopharmaceutical company.

    Job Description:
    The Associate Regulatory Affairs (CMC) role is an entry level regulatory position that provides varying levels of product support to the regulatory Chemistry, Manufacturing and Controls (CMC) department, across regions and phases of development. Support may include organizing, managing, and executing on regulatory CMC projects in support of regulatory submissions. Tasks may include formatting of documents per style guide, searching for and organizing data from regulatory repository systems, drafting meeting agendas and minutes, managing document reviews, and other tasks as requested. What we are looking for:
    • Desire to learn Regulatory Affairs CMC and global submission strategy;
    • Strong organizational skills with attention to detail;
    • Proficient time management skills and ability prioritize workload;
    • Ability to work both independently and as a member of a team;
    • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
    • Qualified to work in the U.S. without employer sponsorship;
    • Commitment of a 40-hour work week in Thousand Oaks,

    Why is the Position Open?
    Supplement additional workload on team

    Top Must-Have Skill Sets:
    • Can-do Attitude – Ideal candidate does not easily give up. The candidate will be provided direction and support but will need to be methodical and analytical when completing tasks while exhibiting a positive attitude (client is a very large organization and there will be many parties the candidate will need to engage with for project success).
    • Being Comfortable With Being Uncomfortable – Ideal candidate will not only be able to identify problems but also identifies possible solutions. Project end goals will be known but all the in-between steps may not be known from the start so the candidate will need to navigate and structure the steps without being easily flustered.
    • Attention to Detail – Ideal candidate will be thorough and deliver polished work product.

    Day to Day Responsibilities:
    Daily responsibilities will be focused on providing submission execution support to products across modalities, regions and phases of development.

    Basic Qualifications:
    • Experience o Bachelor’s or Master's degree with 1 to 2 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience, OR
    • Associate degree and 6 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical or related scientific experience, OR
    • High school diploma / GED and 8 years of either Regulatory, Compliance, Quality, Biopharmaceutical, Pharmaceutical, and/or related scientific experience.

    Preferred Qualifications:
    • Degree in life sciences, biochemistry, or chemistry.
    • Experience in biopharmaceutical or pharmaceutical industry.
    • Familiarity with eCTD structure.
    • Motivated with initiative to learn quickly.
    • Experience in CMC, including preparation of submissions to Agencies.
    • Proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint.

    Red Flags:
    • Leaving assignments before projects are complete.
    • Unexplainable time gaps in resumes.
    • References that are not from recent employers.
    • References that are not direct supervisors.

    Interview process:
    Phone screening followed by in-person interview.


    We invite qualified candidates to send your resume to resumes@3keyconsulting.com.  If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
  • 8 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...
  • 8 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...
  • 21 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...
  • 21 Days Ago

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Associate Regulatory Affairs-CMC
  • Ampcus, Inc
  • Thousand Oaks, CA FULL_TIME
  • What we are looking for: Desire to learn Regulatory Affairs CMC and global submission strategy Strong organizational skills with attention to detail Proficient time management skills and ability prior...
  • 1 Month Ago

3
Associate Regulatory Affairs - CMC (JP10136)
  • 3 Key Consulting
  • Thousand Oaks, CA FULL_TIME
  • Job Title: Associate Regulatory Affairs - CMC (JP10136) Location: Thousand Oaks, CA. 91320 Employment Type: Contract Business Unit: CMC Core Team Duration: 1 years (with likely extensions) Posting Dat...
  • 9 Days Ago

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0 Regulatory Affairs Director jobs found in Ventura, CA area

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Engineering Manager I/II/III
  • Ventura County, CA
  • Ventura, CA
  • Salary : $103,241.38 - $175,012.69 Annually Location : Ventura and Moorpark and may require travel throughout Ventura Co...
  • 4/16/2024 12:00:00 AM

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Director of Research Development
  • RCMA Makeup
  • Simi Valley, CA
  • Company Overview We are a small family run professional makeup company that has been in business for 60 years. Founded b...
  • 4/15/2024 12:00:00 AM

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Senior Center Director
  • CG Staffing Solutions
  • Ventura, CA
  • Job Description Job Description Lead a team of educators as they deliver innovative, high-quality instruction in indoor ...
  • 4/14/2024 12:00:00 AM

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Director, Product Development & Testing - Tools - (On-site at Lab) - Camarillo, CA
  • Harbor Freight Tools
  • Camarillo, CA
  • **This is an on-site role working in our Lab in Camarillo, CA. The Director of Product Development will be responsible f...
  • 4/13/2024 12:00:00 AM

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Head of Regulatory Affairs
  • Hiring Now!
  • West Hills, CA
  • HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
  • 4/12/2024 12:00:00 AM

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RN Clinical Staff Med/Surg/Tele 3rd floor Full Time - Nights
  • Hiring Now!
  • Simi Valley, CA
  • If you are interested please apply online and send you resume to jcardenas@mlkch.org POSITION SUMMARY The Clinical Staff...
  • 4/12/2024 12:00:00 AM

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RN Clinical Unit Supervisor Med Surg/Tele (3rd Floor) Full Time- Days (7am)
  • Martin Luther King Jr. Community Hospital
  • Simi Valley, CA
  • If you are interested please apply online send your resume to j cardenas@mlkch.org POSITION SUMMARY The Clinical Unit Su...
  • 4/12/2024 12:00:00 AM

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RN Med Surg/Tele (4th Floor) Full Time- Nights
  • Hiring Now!
  • Simi Valley, CA
  • If you are interested please apply online and send your resume to jcardenas@mlkch.org POSITION SUMMARY The Clinical Staf...
  • 4/12/2024 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 Director jobs
$181,196 to $258,065
Ventura, California area prices
were up 2.5% from a year ago

Regulatory Affairs Director in Spartanburg, SC
There can be no guarantees with respect to pipeline products that the products will receive the necessary regulatory approvals or that they will prove to be commercially successful.
December 13, 2019
Regulatory Affairs Director in New Brunswick, NJ
The apprenticeship programme lasts 30 months and provides a combination of Masters-level training in regulatory affairs and paid work experience.
February 12, 2020
Regulatory Affairs Director in Syracuse, NY
They often advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues.
January 18, 2020