13 Jobs in Millsboro, DE
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iConsultera is Hiring a Regulatory specialist Near Millsboro, DE
Title : Labeling Specialist
- Under general supervision, responsible for the preparation of high-quality labeling documents for submission to the US Food and Drug Administration (FDA).
- Ensure that product labeling is updated in accordance with FDA regulations and corporate guidelines.
- Ensure prompt availability of labels and artworks and liaises with departments such as Marketing, Pharmacovigilance and Technical Services to ensure compliance with established regulations.
- Maintain databases and team sites by ensuring updated and accurate information is uploaded.
Education : Associate / Bachelor of Life Science / Master's degree.
Required Experience and Skills :
- With Associate, minimum 5 years of relevant experience within pharmaceutical labeling experience
- With Bachelor's, minimum 3 years of relevant experience within pharmaceutical labeling experience
- With Master's minimum 2 years of relevant experience within pharmaceutical labeling experience
- Require someone with scientific background or familiarity with medical terminology.
- Proficient in standard computer programs such as Microsoft Office, Excel, Word, Outlook, and SharePoint.
- Excellent English oral and written communication skills and presentation skills.
- Industry - Pharmaceutical Industry / Vaccine manufacturing / Medical and Biotechnology
Intake notes :
- Hybrid schedule
- Experience would be preferred over a degree.
- Looking for someone with labeling expertise in the pharmaceutical industry, vaccines manufacturing or GMP.
- Software : MS office
Typical day :
- Very intensive label-oriented job
- Need someone to hit the ground running.
- Lot of label review and submission.
- Support the team with the review, revising labeling.
- Attention to details.
- Will review labels on packaging, container, carton boxes.
- Will prepare the label content following SOP’s and FDA regulations.
Last updated : 2024-06-06
Job Summary
Full Time
$63k-82k (estimate)
06/08/2024
06/10/2024
The job skills required for Regulatory specialist include Microsoft Office, Written Communication, Presentation, 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.
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.
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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.
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