18 Regulatory Affairs Manager Jobs in Thousand Oaks, CA
Advanced Bio-Logic Solutions Corp is Hiring a Regulatory Affairs Manager Near Thousand Oaks, CA
Note:
- 100% REMOTE - Needs to support PST time zone (flexible), must support ATO site hours
- Need someone to can hit the ground running
- 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.
- 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)
- 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.
- Change Control evaluation or owner.
- QA, Manufacturing or Operations background experience.
- Process Development experience for biotech products.
- Assess change control records supporting ATO and ESQ areas
- Support submissions with site related documents, as requested
- Provide support for variation process
"This posting is for Contingent Worker, not an FTE"
Job Summary
Full Time
$110k-144k (estimate)
04/17/2024
06/15/2024
The job skills required for Regulatory Affairs Manager include Product Development, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory Affairs Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory Affairs Manager. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory Affairs Manager positions, which can be used as a reference in future career path planning. As a Regulatory Affairs Manager, it can be promoted into senior positions as a Regulatory Affairs Senior Manager that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory Affairs Manager. You can explore the career advancement for a Regulatory Affairs Manager below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Affairs Manager, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Regulatory Affairs Manager for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Affairs Manager job description and responsibilities
Regulatory Affairs Managers plan, direct, or coordinate production activities of an organization to ensure compliance with regulations and standard operating procedures.
04/15/2022: Charleston, SC
They will provide responses to regulatory agencies regarding product information or issues.
04/10/2022: Charleston, SC
They'll establish regulatory priorities or budgets and allocate resources and workloads.
02/22/2022: Temple, TX
Ensures sponsored studies are disclosed according to applicable laws, regulatory requirements and policies.
02/15/2022: Harlingen, TX
The position will provide regulatory review, registration and data management, strategic regulatory advice and submissions to appropriate regulatory agencies.
05/09/2022: New Brunswick, NJ
Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Regulatory Affairs Manager jobs
Having the knowledge and understanding of complex medical and scientific subject matter would give you advantage for this role.
03/10/2022: Springfield, OR
You need the ability to build networks to obtain cooperation.
03/12/2022: Temple, TX
Manager Regulatory Affairs are able to balance projects with day-to-day duties, ensuring participation from other members of the department as needed.
04/10/2022: Great Falls, MT
They utilize their technical skills to ensure products remain safe and efficient by meeting all the regulatory standards.
03/28/2022: Lowell, MA
You need to have IT skills, particularly in relation to using databases and familiarity with commercial software to qualify for this role.
03/28/2022: Anchorage, AK
Step 3: View the best colleges and universities for Regulatory Affairs Manager.
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