Regulatory Affairs Assistant

This position belongs to the quality assurance department and is responsible for ensuring that the
company complies with all standards and laws applicable by regulatory bodies. For greater success in
this field, it is recommended that one start their career in a related field, for example, quality control,
laboratory testing, production, etc. This helps in gaining practical experience in drug development and
its related processes and data interpretation of which technical knowledge is needed. Entry-level
regulatory affairs professionals come from sciences that include chemical engineering, biological
sciences, pharmacy, pharmacology, toxicology, and medicine.

This position has internal relationships with other areas of the company such as quality control to issue
results of developed products, research and development to describe instructions and product
formulation to record and manage the required resources, plant management to test samples of the
products to be registered and the arts department to deliver the Arts of the primary and secondary
packaging of the products to be registered.

As a regulatory affairs assistant, I am the crucial link between the company, its products and regulatory
authorities. I combine knowledge of scientific, legal and business issues to ensure that the products
developed comply with the required legislation. It can take up to 15 years to develop and launch a new
pharmaceutical product, and the regulatory affairs assistant is involved throughout the process, from
the beginning. The role can be challenging as you must meet tight deadlines, therefore you must have
the ability to work under pressure.

Regulatory affairs assistants must understand all aspects of product development, including research,
clinical trials, manufacturing practices, regulations, and approval processes. They help review product
promotional materials, labeling, batch records, specification sheets, or test methods to comply with
applicable regulations and policies. They often advise project teams on topics such as pre-market
regulatory requirements, export and labeling requirements, or clinical study compliance issues.
Additionally, they determine the types of regulatory submissions or internal documentation that are
required in situations such as proposed device changes or labeling changes.

Some typical job tasks include:

 Explain regulations, policies or procedures

 Maintain data in information systems or databases

 Ensure compliance with regulations

 Evaluate applicable laws and regulations to determine the impact on company activities

 Provide technical review of data or reports

 Coordinate regulatory documentation activities

 Identify and interpret relevant regulatory guidance

Additional skills

Working within the regulatory affairs department requires an equal measure of subject knowledge and
skills. A person must possess the following skills to be successful:
 1. Knowledge of the drug development life cycle

2. Attention to detail

3. Critical thinking and data analysis skills

4. Good writing skills

5. Excellent oral and written communication skills (most of the work involves communicating with
internal department staff, clients and regulatory authorities)

6. Organizational and project management skills (work will be varied and limited in time.
Therefore, it is essential to have the ability to juggle different tasks efficiently.)

7. Negotiation skills

8. Ability to stay up to date on current regulations

9. Basic to advanced computer skills

Most of these skills can be learned as part of on-the-job learning. However, this role requires an
individual to go through a large number of documents and be able to analyze the information quickly
and accurately. Therefore, passion for this type of work is very important. It is also important to stay up
to date on regulatory requirements and current industry practices. This can be done by attending
workshops and short courses on relevant topics.

Typically, people in these positions work within a regulatory affairs office where they work on document
preparation, information management, file maintenance, and coordinating tasks across various
departments.