KGK Science is a world-leading contract research organization and provider of clinical research and regulatory services for the Nutraceutical, Rx and OTC Pharmaceutical, Cannabis and Psychedelic Medicine industries.
Reports to: Chief Regulatory Officer
Job Type: Full-Time
KGK Science provides a variety of FDA regulatory services to the Rx and OTC pharmaceutical industry. We offer a seamless approach to help an organization navigate the regulatory intricacies associated with product development, submissions, claims and labeling, manufacturing and packaging of commercial products, as well as facility and product registrations and listings.
Our team of pharmaceutical regulatory experts are ready to provide assistance that will help an organization succeed in this highly complex and very competitive regulatory environment.
KGK is committed to helping the pharmaceutical industry understand and sustain compliance with FDA’s extensive requirements for bringing new products to the drug marketplace.
1. You must have a Doctor of Medicine, Doctor of Osteopathic Medicine, Philosophy Doctorate in toxicology or an appropriate discipline of the biological, medical, or veterinary sciences or equivalent from a school in the United States or Canada.
2. Must have at least 30 semester hours in chemistry, biochemistry, or physiology, and 12 semester hours in toxicology. You may submit transcripts demonstrating both degree and/or coursework as noted in the description above.
Courses in anatomy, chemistry, organic chemistry, biochemistry, biology, histology, and animal, human, microbial, or cellular physiology may be used to meet the 30-semester-hours requirement in chemistry, biochemistry, and physiology.
Courses in statistics, bioassay, and test design may also apply to this requirement. Courses in cytology, embryology, cellular or microbial genetics, and biophysics may also be used to meet this requirement in those instances where the course work provided additional insight into the biophysical, biochemical, and physiological relationships involved.
Only toxicology courses may be used to meet the requirement for 12 semester hours in toxicology. This may include courses dealing intensively with toxicological research, methods in toxicology, essentials of toxicology, the study and review of toxicological literature, special reading courses, or other toxicologically-oriented subjects.
1. Background in FDA or Regulatory Experience in Pharmaceutical Industry (5 years preferred)
2. Experience putting together and submitting IND/NDA submissions
3. Experience in requirements for pre-clinical research for drug development
1) Pharmaceutical Applications and Submissions
KGK assists with all pharmaceutical submissions and amendments to FDA and Health Canada. Our scientific experts in toxicology, radiology, chemistry and biology are authorities in government laws, federal/state regulations, and agency guidance documents. KGK leads companies through the process of obtaining necessary background data in support of a submission, filing the submissions via eCTD, and following-up as needed during the submission process.
NDA or New Drug Applications: Drug sponsors may petition FDA for approval of a new pharmaceutical for sale and marketing in the US through a NDA, or 505(b)(2) application. The pharmaceutical regulatory professional will assist with the preparation and filing of an NDA, including the gathering of appropriate data and, if required, the design of and execution of studies that facilitate FDA’s review and determination of whether the benefits of a drug outweigh the potential risks, whether the proposed packaging and insert is appropriate and whether manufacturing methods allow for adequate preservation of identity, strength, quality, and purity.
ANDA, or Abbreviated New Drug Applications: ANDAs for generic drugs are “abbreviated” because data safety and effectiveness are generally not required, with a demonstration of bioequivalence to an approved reference drug used instead. The pharmaceutical regulatory professional at KGK will prepare ANDA submissions ensuring all technical aspects of bioequivalence are accurately and authoritatively answered.
Drug Master Files (DMF): The pharmaceutical regulatory professional prepares DMF submissions for clients which provide detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drugs in support of an IND, NDA, ANDA, another DMF, and Export Applications.
Investigational New Drugs (IND): The pharmaceutical regulatory professional prepared IND applications including preclinical data showing the product is safe for testing in humans; all required information regarding the manufacturer, composition and stability for manufacturing as well as protocols which will be used in the clinical studies to assess whether subjects will be exposed to unnecessary risks.
New Animal Drug Applications (NADA) and Abbreviated New Animal Drug Applications (ANADA): The pharmaceutical regulatory professional at KGK will assist with the development and submission of NADAs and ANADAs. Similar to NDAs for human foods, NADA sponsors may petition the FDA for approval of a new pharmaceutical for sale and marketing in the US using the data gathered during the animal studies. Additionally, ANADAs are generic drug “abbreviated” as the petitioner is generally not required to submit preclinical and clinical data to establish safety and effectiveness, using a demonstration of bioequivalence instead.
2) Over the Counter (OTC) Drug Product Submissions Monographs and Other Assistance
OTC (nonprescription) drug products, including homeopathics, are marketed as OTC drug monographs, categorized by therapeutic classes, which provide a “recipe” for permitted active ingredients, dosages and labeling. The KGK pharmaceutical regulatory professional develops and reviews monographs as well as prepared filing submissions and responses to Agency initiatives concerning OTC drug applications specific to this drug class.
3) Drug Labeling and Claims Substantiation Support
KGK’s pharmaceutical regulatory profession will be highly familiar and experienced with requirements for pharmaceutical and OTC drug labels. KGK can review formatting, nutrition information, and claims, ensure structure/function claims are appropriate and identify when both cosmetic and drug claims can be included in labeling certain products.
Structured Product Labeling is a document markup standard approved by Health Level Seven (HL7) and adopted by FDA as a way to exchange product and facility information for the pharmaceutical establishment and product registration. The KGK pharmaceutical regulatory profession will provide a number of services related to SPL registrations including preparation and submission of the SPL establishment registration, product listing (Rx, OTC, Homeopathic drug products), Labeler Code Requests, and GDUFA self-Identification files.
4) eCTD (Electronic Common Technical Document)
KGK provides eCTD writing services and can assist an organization in submitting eCTDs. Once submission is compliant with FDA requirements, KGK may submit the file on your company’s behalf, or return the final product for self-submission through the FDA eportal gateway. We also offer the ability to review submissions of a claim prior to them sending to FDA to ensure regulatory compliance and completeness, expediting FDA’s time-in-review.
5) Protocol Development – Pharmaceuticals and Psychoactives
KGK’s pharmaceutical regulatory professional will also be responsible for developing novel-design clinical drug protocols for IND and other regulatory submissions. They will be expected to work independently and work with our team of experts in the Research Branch to tailor active pharmaceutical ingredients (API) or psychoactive protocols in accordance with our partner clients.
You can live anywhere in the U.S. or Canada. Work will be remote, but you could be expected to join your professional peers in London, Ontario at KGK Science Headquarters as much as one week out of a month.
If interested in the position, please submit your resume and a cover letter
We are an equal opportunity employer and thank all those who apply. Only those selected for an interview will be contacted.