8 regulatory specialist i Jobs in saint paul, mn
Bell International Laboratories is Hiring a Regulatory specialist Near Saint Paul, MN
The Regulatory Compliance Specialist, within the Quality Assurance department, is a dedicated professional who ensures adherence to regulatory compliance aligned with cGMP and current requirements.
This individual aids in the day-to-day quality management activities within Bell Labs, ensuring alignment with both company and regulatory requirements.
Responsibilities
- Support our customers through provision of requested regulatory documentation.
- Coordinate and prepare routine submissions for FDA and other regulatory entities.
- Monitor applicable regulatory requirements to assure compliance with domestic and foreign regulatory standards.
- Maintain regulatory approvals and associated files. Build and maintain regulatory library .
- Provide regulatory feedback to R&D regarding proposed product ingredient lists.
- Evaluate customer artwork for adherence to regulatory compliance.
- Support R&D during development process to ensure formulas are compliant in the applicable regulated countries.
- Identify and create efficiencies in the facilitation of regulatory processes.
- Actively participate in internal audits, customer audits and other activities as assigned by manager.
Required Skills / Abilities
- Ability to effectively build and maintain relationships, communicating and interacting in a matrix environment.
- Strong organizational skills, with a keen eye for reviewing and editing documents.
- Ability to maintain meticulous attention to detail and precision while juggling multiple tasks.
- Excellent written, verbal and interpersonal communication skills
- Proficiency in Microsoft Office and Adobe Acrobat
Required Education and Experience
- BS / BA in science, engineering, quality / regulatory studies, or equivalent industry experience in pharmaceutical regulatory affairs.
- A quality professional with 2-5 years of hands-on experience in regulatory management within the regulated pharmaceutical industry, including direct regulatory experience.
Preferred Education and Experience
- Exhibit a quality mindset and a willingness to develop yourself and others.
- Demonstrated knowledge of GMPs, 21 CFR 210 and 211 and other regulatory agency requirements sufficient to apply to quality operations and compliance.
- Audit or inspection experience preferred.
Last updated : 2024-05-23
Job Summary
Full Time
Pharmaceutical
$68k-87k (estimate)
05/25/2024
08/24/2024
bellinternationallabs.com
EAGAN, MN
200 - 500
2010
MO SAREMI
$50M - $200M
Pharmaceutical
Related Companies
The job skills required for Regulatory specialist include Regulatory Compliance, Microsoft Office, Attention to Detail, Quality Assurance, Quality Management, Organizational Skills, 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.
04/06/2022: Wilmington, NC
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
04/13/2022: San Antonio, TX
Certified regulatory affairs specialists typically collect and review marketing, legal, regulatory and licensing documentation, case files, studies, reports, etc.
02/13/2022: Manchester, NH
Responsible for filing necessary applications and handling all government interactions pertaining to the regulation process for products requiring governmental approval.
02/10/2022: Santa Fe, NM
works to help a company or organization meet all state, local, federal, international, and industrial regulations that apply to their products.
04/11/2022: Baton Rouge, LA
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.
03/19/2022: Ann Arbor, MI
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.
Similar Jobs
Popular Articles
