Drug Regulatory Affairs and Career Options

Drug Regulatory Affairs | Regulatory Affairs | Regulatory Affairs Jobs | What is Regulatory Affairs | Drug Regulatory Affairs Salary

Introduction

The Regulatory Affairs (RA) department of a pharmaceutical company is responsible for obtaining authorization of new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product in the market. A new class of professionals emerged to handle these regulatory matters for pharmaceutical organization. It serves as the interface between the regulatory authority and the project team, and is the channel of communication with the regulatory authority such as the Food and Drug Administration (FDA) as the project proceeds, aiming to ensure that the project plan correctly anticipates what the regulatory authority will require before approving the product.

It is the responsibility of RA to keep abreast of current legislation, guidelines and other regulatory intelligence such as International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The job of the drug regulatory affairs professionals usually found at every level and there is a high demand of qualified professionals in this field. 

Essential Qualification Required to Pursue a Career In Regulatory Affairs

 

·         Degree Courses

·         B.Sc/M.Sc in Regulatory Affairs/Life Sciences

·         B.Pharm/ M.Pharm

·         PhD in Drug Regulatory Affairs/life sciences

·         BAMS/ BHMS/ BDS

 

Certificate course or a post-graduate diploma in Drug Regulatory Affairs can also form the basis to enter in the field; however postgraduate degree or PhD degree will have added advantage compared to certificate courses or bachelor degree only.  

Study Topics in Drug Regulatory Affairs (DRA)

The knowledge on the following topics could make a Drug registration procedure smooth without any significant delays/failures,

•      DRA objectives,

•      Terminologies and Basic Understanding related to DRA,

•      Essential qualities of Regulatory Affairs Professional,

•      The USFDA Drug Approval Procedure and regulatory requirements,

•      History of US Drug Law and Regulations,

•      Worldwide Agencies for drug regulations,

•      Investigational New Drug Application (INDA),

•      New Drug Application (NDA),

•      Abbreviated New Drug Application (ANDA),

•      Supplemental New Drug Application (sNDA),

•      Orange Book and Purple Book,

•      Drug Master File (DMF),

•      Common Technical Document (CTD),

•      Electronic Common Technical Document (eCTD),

•      Regulatory Strategy,

•      GMP and cGMP,

•      Clinical Research,

•      Biologics License Application (BLA),

•      Important Literature Search Websites for DRA Professionals and many more...

Potential Recruiters

 

Potential employers include government agencies and private companies that manufacture the following products:

·         Pharmaceuticals

·         Medical devices

·         Biotechnological products

·         Herbal and homeopathic medicinal products

·         Food and nutritional products

·         Agrochemicals

·         Cosmetics

·         Veterinary products 

Roles and Responsibilities of Regulatory Affairs Professional

 

A regulatory affairs professional acts as a linkage between its employer, its product and the regulatory agencies. The role involves:  

·   Preparation and submissions of registration dossier for regulatory agency approval and carrying out any subsequent negotiations necessary to obtain or maintain marketing authorisation for the products concerned

·      Ensuring company’s products compliance with agencies guideline

·      Collecting, collating and evaluating scientific data as per latest regulations

·      Advising company’s other departments on regulatory requirements

·      Providing tactical advice to company for the entire drug development cycle

·      Advising on the registration process and scientific restraints and requirements   

·      Advising on legal requirements and replying to the regulatory agency queries  

Salary Structure 

There is a great demand of regulatory affairs professional and the salary structure is very lucrative and the professionals and experts in this field are very highly paid.

 

India	Germany	UK	US	Canada
₹ 1.4 to ₹ 5.6 Lakhs, avg annual salary of ₹ 3.0 Lakhs	€57,173 per year	£51,252 per year	$37,390 to $145,000 per year	$88,605 per year
* average salary for 0-3 years experienced professional     *Salary based search from different job portals

Summary 

Positions within regulatory affairs offer excellent job security. The reason is imbalance between supply and demand. There are not enough people today have experience in regulatory affairs and at the same time, worldwide regulatory agencies such as FDA and EMA has increased its standards, requiring more supporting clinical and animal studies and paperwork before products are approved for human use.