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Overview
Cook MyoSite, Inc., part of the Cook Group, Inc. family of companies, is on a mission to make regenerative medicine a part of everyday medicine.
We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders.
We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours.
Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.
The Regulatory Publishing Specialist II at Cook MyoSite, Inc. is responsible in aiding in the compilation, coordination, and submission of documents to the .
Food and Drug Administration and other Regulatory agencies, as well as providing Regulatory Operations support.
Responsibilities
Preparation, coordination / compilation of Regulatory submissions, publications, and filings to . FDA and other Regulatory agencies, including but not limited to :
INDs, BLAs, amendments, supplements, DMFs, annual reports, ADEs, Drug Registration Listing, packaging and labeling, and other regulatory filings
familiarity with ICSRs and FAERS portal submissions
Skilled in Adobe Acrobat DC, Lorenz Validation (or other publishing systems),
Qualifications
Physical Requirements :
Last updated : 2024-06-17
Full Time
Medical Technology
$63k-83k (estimate)
06/18/2024
06/22/2024
cookmedical.com
BLOOMINGTON, IN
3,000 - 7,500
1963
M KEM HAWKINS
$500M - $1B
Medical Technology
The job skills required for Regulatory specialist include Regulatory Affairs, Product Development, Coordination, Project Management, PowerPoint, Integrity, etc. Having related job skills and expertise will give you an advantage when applying to be a Regulatory specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Regulatory specialist. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Regulatory specialist positions, which can be used as a reference in future career path planning. As a Regulatory specialist, it can be promoted into senior positions as a Regulatory Affairs Specialist II that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Regulatory specialist. You can explore the career advancement for a Regulatory specialist below and select your interested title to get hiring information.
If you are interested in becoming a Regulatory Specialist, 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 Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Regulatory Specialist job description and responsibilities
The regulatory specialist creates and maintains regulations for testing processes, the development phase, how production operates and the marketing and distribution for new products.
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Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
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Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
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Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
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works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
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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 Specialist jobs
Entry-level regulatory affairs professionals must have a bachelor’s degree.
02/23/2022: Chico, CA
Successful regulatory specialists are excellent writers, as they must write details and accurate reports for the evaluations they perform.
02/24/2022: Newport News, VA
Earn Regulatory Affairs Professionals Society certifications.
03/14/2022: Saint Paul, MN
On successful completion of the program, graduates can take up roles such as regulatory affairs specialists.
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At conferences and forums, specialists develop their existing knowledge and learn about emerging regulations, standards, and guidance documents.
04/28/2022: Lowell, MA
Step 3: View the best colleges and universities for Regulatory Specialist.