11 REGULATORY SPECIALIST I Jobs in Bethesda, MD
TECHNICAL RESOURCES INT'L is Hiring a REGULATORY SPECIALIST I Near Bethesda, MD
- Prepare, distribute, and track regulatory submissions including, drug and biologic Investigational New Drug Applications (INDs), Biologics License Application (BLAs), New Drug Application (NDAs), Investigational Device Exemption (IDEs), ensuring compliance in accordance with GCPs/ICH and all applicable FDA/other Regulatory Health Authority regulations.
- Prepare scientific and other regulatory documents for submission to the Food and Drug Administration (FDA) and other Health Authorities.
- Attend scientific meetings and reviews the literature to stay current with new developments in the infectious disease field (in particular, human immunodeficiency virus (HIV) and tuberculosis (TB)) and therapeutic clinical research.
- Performs literature searches, attend meetings, etc. as needed to support regulatory document preparation, regulatory intelligence, and regulatory strategy, and to stay current with applicable therapeutic areas of clients.
- Excellent oral and written communication skills; detail-oriented and able to multi-task/prioritize well.
- Ability to analyze medical research data and review experimental protocols.
- Strong working knowledge of Microsoft office; experience with SharePoint a plus.
- Professional or educational background in a scientific field, clinical trials, regulatory affairs or health care; familiarity with GCP and/or experience working in an FDA-regulated environment is desirable. General knowledge of the drug/vaccine development process or clinical trials is a plus.
- Experience in preparing regulatory documents, publishing regulatory submissions using?electronic publishing software and proficiency in preparing documents that are compliant with electronic submission standards.
Job Summary
Full Time
$73k-95k (estimate)
05/25/2023
05/19/2024
The job skills required for REGULATORY SPECIALIST I include Regulatory Affairs, Clinical Trial, Written Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a REGULATORY SPECIALIST I. 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 I. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for REGULATORY SPECIALIST I positions, which can be used as a reference in future career path planning. As a REGULATORY SPECIALIST I, 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 I. You can explore the career advancement for a REGULATORY SPECIALIST I 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.
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