Indi Swift Regulatory affairs Sr Officer to Executive Level Job Vacancy 2022
- 1. What is Drug Registration ?
- 2. What are Regulations / Directives?
- 3. What are Guidelines?
- 4. What is Marketing Authorization ?
- 5.What is Evaluation ?
- 6. What is the reason behind change the name of EDQM as EDQM & Health Care ?
- 7.How many types of E-DMFs are in place ?
- 8. How many types of USDMFs are in place ?
Ind-Swift is hiring energetic and enthusiastic candidates for the corporate DRA team. ( drug Regulatory affairs )
Experience: 2-5 years
Designation: Sr. Officer/ Executive Salary: Negotiable (Based on the interview)
Location: Derabassi, Near Chandigarh (Punjab)
Must have exposure in Dossier Preparation and Submissions for US/EU market preferably in API.
The candidate must be flexible to relocate.
Interested candidates share their CVs at hr.jobs@indswiftlabs.com or Contact 8968374200
Some of the Common Regulatory affairs Basic Questions.
1. What is Drug Registration ?
Once a product has been given authorization for Marketing or free distribution and Entitlement such as first- track procedures, ect.
2. What are Regulations / Directives?
Regulations / Directives are a form of law, sometimes referred to as subordinate legislation, which define the application and enforcement of legislation. Regulations / Directives are made under the authority of an Act, called an Enabling Act.
Regulations / Directives are enacted by the body to whom the authority to make Regulations / Directives has been delegated in the Enabling Act, such as the Governor in Council or a minister, etc.
Regulations are USFDA terminology. Directives are EMEA / EDQM terminology.
3. What are Guidelines?
Guidelines are departmental documents that are used to interpret legislation and / or regulation. Although they may be
derived from legislation and are often used to advise how one might comply with a regulation, guidelines do not have the force of law.
4. What is Marketing Authorization ?
Official document issued by the competent Drug Registration Authorities for the purpose of marketing of a product after evaluation for Quality, Safety and Efficacy.
5.What is Evaluation ?
Interpret the data and determine if the product has acceptable Quality, Safety and Efficacy.
6. What is the reason behind change the name of EDQM as EDQM & Health Care ?
European Directorate for the Quality of Medicines (EDQM) was extended to cover two more new areas, i.e., organic
transplantation and blood transfusion. So the EDQM & Health Care was started from 14.12.2006 onwards.
7.How many types of E-DMFs are in place ?
Type A : New Active Substances
Type B : Existing Active Substances not included in the EP or Pharmacopoeia of an EU Member State.
Type C : Pharmacopoeial Active Substances included in the EP or Pharmacopoeia of an EU Member State.
DMF holders should update their DMFs for every five years (Quinquennial Update).
8. How many types of USDMFs are in place ?
Type I : Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer available)
Type II : Drug Substance, Intermediate, and Material used in their preparation or Drug Product
Type III : Packaging Material
Type IV : Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V : FDA Accepted Reference Information
DMF holders should update their DMFs annually (Annual Update). FDA is in the process of sending Overdue
Notification Letters (ONLs) to DMF holders that have not been updated, i.e., no amendments or annual reports in
three years.
If a DMF holder does not respond to this letter within 90 days, the DMF is retired and is unavailable for review. U.S. standard paper size (8-1/2 by 11 inches) is preferred for USDMF.
Some DMFs may be listed as inactive which are, in fact, still active. Every effort will be made to correct any errors.
The following types of DMFs may be filed as Type V DMFs without requesting prior clearance from FDA :
Manufacturing Site, Facilities, Operating Procedures, and Personnel for sterile manufacturing plants. Contract Facilities for the manufacture of biotech products.
