Regulatory Affairs Specialist jobs in Kingsport, TN

Regulatory Affairs Specialist supports the oversight of regulatory matters and strategy implementation to ensure the organization complies with applicable regulations. Prepares filings and tracks applications for licensing, certification, and permits and interacts with governmental officials during the regulation and certification process. Being a Regulatory Affairs Specialist monitors compliance with existing regulations and upcoming or changing regulations. Performs impact analysis of regulatory changes and produces status reports. Additionally, Regulatory Affairs Specialist participates in processes to report, investigate, and addresses any issues of non-compliance. Typically requires a bachelor's degree. Typically reports to a supervisor or manager. The Regulatory Affairs Specialist occasionally directed in several aspects of the work. Gaining exposure to some of the complex tasks within the job function. To be a Regulatory Affairs Specialist typically requires 2 -4 years of related experience. (Copyright 2024 Salary.com)

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Senior Associate, Regulatory Affairs
  • USAntibiotics, LLC
  • Bristol, TN FULL_TIME
  • Overview

    USAntibiotics, the only U.S. manufacturer of Amoxicillin products, is part of the Jackson Healthcare family of companies. We're always looking to add new talent to our teams, and we value diverse professionals who have strong leadership skills, align with our culture, and are committed to excellence.

    Responsible for support of regulatory affairs activities under direction of department management. Activities may include but are not limited to:
    *Compilation/review of Annual Reports, Advertising/Promotional material, and product labeling.
    *Electronic assembly and publication of original applications, amendments, and supplements.
    *Assessment of proposed changes to manufacturing facilities, processes, and/or controlled documents.

    ROLES & RESPONSIBILITIES:

    • Product support activities: Compilation and review of FDA Submissions (e.g., NDA Filings, Amendments, Supplements, Annual Reports, DMF Updates, labeling packages) as agreed upon with change control review/approval and management.
    • Coordinate compilation/review of Advertising/Promotional material with marketing for management's review and approval.
    • Submit Advertising/Promotional materials to FDA's OPDP via electronic methods.

    QUALIFICATIONS:

    Additional responsibilities as assigned by management.
    • Bachelor's degree in a scientific area of interest required (e.g., chemistry, microbiology/biology, pharmacy, premed, nursing).
    • Minimum of four years of direct pharmaceutical industry experience or solid equivalent work experience in a cGMP and/or FDA regulated environment.

    KNOWLEDGE, SKILLS AND ABILITIES:

    Competency with regulations, policies, and procedures relating to company and regulatory guidelines

    • Ability to multitask and manage multiple projects with interdisciplinary teams
    • Effective communication (verbal and written) with external and internal customers, vendors, and regulators.
    • Participation and familiarity with post-approval submissions to FDA, and with ad/promo materials to FDA as well as hands-on experience reviewing and approving labeling and marketing regulatory materials.
    • Strong planning and organizational / project / workload management skills.
    • Ability to work under deadline pressure / rapidly shifting priorities and manage multiple projects.
    • Strong ability to work independently as well as in a team environment.
    • Ability to drive projects to completion with minimal guidance.
    • Solid interpersonal (verbal and written) communication skills at all levels.
    • Formal project management skills are a plus.
    • Broad career progression including experience in multiple departments in pharmaceutical, drug development and/or manufacturing industry is a plus. Regulatory publication experience using eCTD software is a plus.
    • Experience in the use of PC-based word processing software, databases, spreadsheets, and Adobe Acrobat,including database management and support. SAP experience a plus.
    • Proficient in the use and preparation of electronic regulatory submissions under FDA and ICH Common Technical Document (CTD) XML-compliant schema is preferred.
    • Experience with metrics management and reporting.
    • Proven negotiation skills with internal and external stakeholders.

    EEO Statement

    USAntibiotics is an EEO/AA Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sexual orientation, gender, gender identity and expression, national origin, age, disability or protected veteran status. We celebrate diversity and are committed to creating an inclusive environment for all of our associates.

     

  • Just Posted

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Kingsport, TN FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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Executive Director, Advertising & Promotions Regulatory Affairs
  • Bausch Health
  • Johnson, TN FULL_TIME
  • Bausch Health is a global company that develops, manufactures, and markets a differentiated product portfolio across multiple high-growth therapeutic areas including Gastroenterology, Generics, Neurol...
  • 10 Days Ago

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Business Affairs Assistant II
  • KCTCS Careers Site
  • Hazard, KY FULL_TIME
  • Title: Business Affairs Assistant II Salary Range: $27,600.00 annual, may be higher with additional related experience Contract Term Length: 12 Months Standard Hours: 37.5 per week Work Location: On-S...
  • Just Posted

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Business Affairs Assistant II
  • KCTCS
  • Hazard, KY FULL_TIME
  • Business Affairs Assistant II Hazard, KY Hazard Community & Technical College Staff Full-time Hazard Community & Technical College Add to favorites Favorited View favorites Title : Business Affairs As...
  • 1 Month Ago

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Vice President for Academic Affairs and Workforce Solutions
  • Mountain Empire Community Coll
  • Wise, VA FULL_TIME
  • Posting Summary Working Title Vice President for Academic Affairs and Workforce Solutions Role Title 12 month Administrative Faculty Role Code 01126-SW FLSA Exempt Pay Band 00 Position Number 299FA004...
  • Just Posted

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0 Regulatory Affairs Specialist jobs found in Kingsport, TN area

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Commercial Loan Officer
  • FIRST BANK AND TRUST COMPANY
  • Kingsport, TN
  • Job Description Job Description First Bank and Trust is seeking a Commercial Loan Officer for our Kingsport, TN office. ...
  • 3/28/2024 12:00:00 AM

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Psychiatrist -C&Y- Full Time- Holston C&Y
  • Frontier Health
  • Kingsport, TN
  • JOB TITLE Psychiatrist SUMMARY: Will provide direct professional psychiatric services to patients as assigned to include...
  • 3/28/2024 12:00:00 AM

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HR Generalist
  • Comfort Systems USA Shoffner Kalthoff MES
  • Blountville, TN
  • Comfort Systems USA - Bristol is looking for a Human Resources Generalist to join the team in Blountville, TN. We are lo...
  • 3/28/2024 12:00:00 AM

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RN - Assistant Nurse Manager (FT) Days, Nursing Admin - Johnson City, TN
  • Nursing Administration
  • Johnson City, TN
  • RN - Assistant Nurse Manager (FT) Days, Nursing Admin - Johnson City, TN Job ID: 004BT3 JOHNSON CITY MEDICAL CENTER Lead...
  • 3/28/2024 12:00:00 AM

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Pharmacist, Clinical Spec. *SIGN ON BONUS PGY-2* (FT) Pediatric-Johnson City, TN
  • Ballad Health
  • Johnson City, TN
  • Pharmacist, Clinical Spec. *SIGN ON BONUS PGY-2* (FT) Pediatric-Johnson City, TN Job ID: 004DN4 NISWONGER CHILDRENS HOSP...
  • 3/28/2024 12:00:00 AM

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Registered Nursing- RN - Long Term Care/Skilled Nursing Facility (Kingsport, TN)
  • CareerStaff Unlimited
  • Kingsport, TN
  • Registered Nursing- RN - Long Term Care/Skilled Nursing Facility Invest in your future by discovering a facility in King...
  • 3/27/2024 12:00:00 AM

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Mobile Driver/Screener (FT) Varied - Johnson City, TN
  • Community Health Clinical Resources
  • Johnson City, TN
  • Mobile Driver/Screener (FT) Varied - Johnson City, TN Job ID: 004CWN BALLAD CORPORATE Support Services - Community Healt...
  • 3/27/2024 12:00:00 AM

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Commercial Relationship Manager
  • First Horizon
  • Kingsport, TN
  • About UsFirst Horizon Corp. (NYSE: FHN), with approximately $90 billion in assets, is a leading regional financial servi...
  • 3/26/2024 12:00:00 AM

Kingsport is located in western Sullivan County at 36°32′N 82°33′W / 36.533°N 82.550°W / 36.533; -82.550 (36.5369, −82.5421), at the intersection of U.S. Routes 11W and 23. Kingsport is the northwest terminus of Interstate 26. US 11W leads east 22 miles (35 km) to Bristol and southwest 28 miles (45 km) to Rogersville, while US 23 leads north 38 miles (61 km) to Big Stone Gap, Virginia. I-26 and US 23 lead south 8 miles (13 km) to Interstate 81 and 83 miles (134 km) to Asheville, North Carolina. The city is bordered to the west by the town of Mount Carmel, to the southeast by unincorporated ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Specialist jobs
$66,131 to $88,624
Kingsport, Tennessee area prices
were up 1.3% from a year ago

Regulatory Affairs Specialist in Long Beach, CA
In addition to keeping informed of licensing and legal documentation requirements, a regulatory affairs specialist is involved in less-visible yet vastly important industry issues, such as packaging and labeling.
December 16, 2019
Regulatory Affairs Specialist in Albuquerque, NM
Coordinate and document internal regulatory processes, such as internal audits, inspections, license renewals, or registrations.
February 20, 2020
Regulatory Affairs Specialist in Petaluma, CA
Becoming a regulatory affairs specialist is one of the most common ways to break into the industry.
February 10, 2020
The regulatory affairs industry plays an important role in ensuring the safety of countless products that Americans use every day—from food and beverages to pharmaceuticals and medical devices to electronics and more.
February 02, 2020