7.5 RESPONSIBILITY OF REGULATORY AFFAIRS PROFESSIONALS

Drug development involves a huge amount of money as well as time. This arises the

need for effective management of the approval process and post-approval maintenance

process. The drug regulatory affairs professional plays an important role in every phase

of these processes. The drug regulatory professionals are highly qualified and

experienced in their respective fields. There are some qualities which make efficient

regulatory professionals. These are:

i. Good communication skills

ii. Good computer knowledge

iii. Work independently

iv. Active listeners

v. Good presenter

vi. Good data management skills

vii. Patient worker

viii. Effective negotiator

ix. Punctual

x. Have sound knowledge

Because of the critical nature of this job, there are several important responsibilities

of regulatory affairs professionals. These are as follows:

Ensuring the compliance: Regulatory affairs professionals ensure that their

companies comply with the guidelines, policies and laws related to their business.

Ensuring the ease of business: Regulatory affairs professional ensure the ease of

business for their company. The effective and efficient communication with regulatory

agencies and concerned staff on specific issues related to drug approval or renewal

makes the business easy for the company.

Ensuring effective communication: It is the responsibility of regulatory affairs

professionals to effectively present the documents in front of regulatory authorities

and discuss the application related issues.

Ensuring effective coordination: Any query, change in guidelines, change in

application, etc. need to be addressed by regulatory affairs professionals. The

professionals ensure the collection of accurate data or response from the related

department and send it to the concerned authority.

Applying and monitoring drug approval application: It is the responsibility of

regulatory affairs professionals to prepare the application for the drug approval process.

The professionals are the one who decides the mode of applying, and the documents

need to be attached as per guidelines. After applying, it is the responsibility of the

regulatory affair professionals to check its status and progress.

120 Industrial Pharmacy II

Updating the changes: Guidelines related to the drug regulation keep on changing

as per the requirements and become stricter. It is the responsibility of regulatory affairs

professionals to remain updated with the changes and ensure the compliance of the

company’s business with these changes.

Assisting product launching: Various activities related to product launching like

reviewing advertising material, presenting the product, marketing strategies for

product, etc are assisted by regulatory affairs professionals so that to ensure compliance

with rules and guidelines.

Reviewing of documents: There are many documents which need to be submitted

with the drug approval application. The regulatory authority mentioned specific format

for these documents in their regulatory guidelines. Regulatory affairs professionals

review these documents to ensure that the documents are the same as expected by the

regulatory authority.

Liaisoning between authorities and companies: This is the most important and

critical responsibility of regulatory affairs professionals. He is the presenter of the

company in front of government authority. Any loophole in the preparation of

regulatory affairs professionals cost a huge to the company. Regulatory affairs

professionals have to maintain the balance between expectations of government

authorities and profit of the company through his strategic solutions.

Miscellaneous: It is the responsibility of regulatory affairs professionals to regulate

and control any activity which directly or indirectly affects the drug development

process, drug approval process, or drug monitoring process.