Career opportunities in the healthcare sector are thriving due to the increasing population and new medical challenges. These require adherence to the government laws and regulations. Throughout the entire process, from development to implementation. One vital area within the pharmaceutical industry is drug regulatory affairs, which ensures that drugs and medical devices are safe and effective for their intended purposes. Read on to learn more.

Eligibility for working as a drug regulatory affairs personnel

Drug regulatory affairs personnel must be highly equipped with knowledge and expertise in their relevant fields to get enrolled in drug regulatory affairs courses. The criteria they must fulfill are mentioned below.

•              Educational qualification

Earn a bachelor’s degree in the relevant fields of chemistry, biochemistry, pharmacy, biological sciences, etc. Candidates with pharmacy degrees have an added advantage in pursuing a career as a drug regulatory personnel. Higher educational qualifications like master's degrees, doctorates, and post-doctorates in research fields of relevant subjects can help you qualify as an advanced drug regulatory officer. 

•              Experience

The competitive job of a certified drug regulatory officer demands knowledge with experience. Start with an entry-level job to gain knowledge and skills from practical experience and gradually work up the ladder to advanced positions like a drug regulatory affairs specialist etc. You can also opt for internships while obtaining your bachelor’s degree. These experiences count for teaching you about the administrative aspects of this field. 

•              Certification 

A certificate course in drug regulatory affairs helps with the understanding of the important stages of the industrial lifecycle of medicines, technologies, and their adherence to specific regulations that are mandatory in the Pharma industry. The course includes gaining knowledge on government compliances, regulatory strategies,  product approvals stages, etc. Enroll today to be a certified drug regulatory affairs professional with Company Connect Consultancy. They provide free training materials for the preparation of qualifying for the exams. 

Sectors of the Pharma industry that require certified drug regulatory personnel

A certificate course in regulatory affairs will enable you to prepare and submit applications to regulatory agencies for marketing approval, ensure compliance of drugs and medical devices with the latest laws and regulations, perform regulatory audits, and many more. The various sectors in which they can work are as follows:

•              Pharmaceuticals

Regulatory officers in this sector are responsible for compliance with regulations, responding to regulatory inquiries about the company’s product, supervising product development until it reaches the market, navigating global regulations for drugs, etc. 

•              Medical devices

Regulatory officers help organizations get approvals from government authorities making sure they adhere to the latest laws and regulations. They collect, collate, and evaluate scientific data that is useful in obtaining or renewing licenses for medical devices.

•              Biopharmaceuticals

A certified drug regulatory officer acts as a regulatory liaison between the regulatory authority and the project team. Job in this sector involves designing product labels and patient leaflets, inspections, and regulatory advice. 

•              Government institutions

As a government drug regulatory affairs officer you will be responsible for the approval of medical products like drugs, devices, etc taking into consideration their compliance and safety. They also act as a communicator between regulatory agencies and Pharma companies addressing queries and receiving responses. 

Conclusion 

The global market of pharmaceutical regulatory affairs valued at around 5 billion dollars is expected to grow significantly. A drug regulatory affairs certification course will help you land a secure job that is high in demand with competitive salaries.