Recent Searches

You haven't searched anything yet.

2 Regulatory Specialist Jobs in Bethesda, MD

SET JOB ALERT
Details...
tech-res
Bethesda, MD | Full Time
$69k-89k (estimate)
6 Months Ago
TECHNICAL RESOURCES INT'L
Bethesda, MD | Full Time
$73k-95k (estimate)
0 Months Ago
Regulatory Specialist
tech-res Bethesda, MD
$69k-89k (estimate)
Full Time | Scientific Services 6 Months Ago
Save

tech-res is Hiring a Regulatory Specialist Near Bethesda, MD

Job Title
Regulatory Specialist
Location
Bethesda, MD 20817 US (Primary)
Category
Regulatory Affairs
Job Type
Full-Time
Education
Bachelor's Degree
Travel
None
Job Description
  • 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.
Job Requirements
  • 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.
We are equal opportunity/affirmative action employers, committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status, or any other protected characteristic under state or local law.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Scientific Services

SALARY

$69k-89k (estimate)

POST DATE

11/21/2023

EXPIRATION DATE

06/25/2024

WEBSITE

tech-res.com

HEADQUARTERS

BETHESDA, MD

SIZE

100 - 200

FOUNDED

1979

TYPE

Private

CEO

NORA LEE

REVENUE

$10M - $50M

INDUSTRY

Scientific Services

Related Companies
About tech-res

TRI provides product development support services to the global drug, biologic and medical device community.

Show more

tech-res
Full Time
$55k-69k (estimate)
Just Posted
Full Time
$98k-119k (estimate)
3 Weeks Ago
tech-res
Full Time
$97k-117k (estimate)
2 Months Ago

The job skills required for Regulatory Specialist 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. 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.

For the skill of  Regulatory Affairs
System One
Other
$139k-185k (estimate)
3 Months Ago
For the skill of  Clinical Trial
Allen Spolden
Full Time
$100k-131k (estimate)
2 Months Ago
For the skill of  Written Communication
Montgomery County Public Schools
Full Time
$45k-90k (estimate)
Just Posted
Show more

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.

TECHNICAL RESOURCES INT'L
Full Time
$73k-95k (estimate)
0 Months Ago

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.

Butler University
Carroll College
Providence College
Rollins College
Taylor University
Amherst College
Show more