Roles and Responsibilities- Regulatory Specialist
Author : Mack Shah | Published On : 28 Mar 2024
The use of Biotechnology can be seen in our everyday lives. With the increasing population of the World, the demand for innovations is also increasing, resulting in numerous jobs in Biotechnology. You can check out www.biostaffic.com to learn more about Biotech jobs.
Regulatory affairs play a crucial role in any biotechnology company as it ensures the safe and effective making of healthcare products, including pharmaceuticals and medical devices. Organizations accountable for the creating, manufacturing and marketing of medical products must certify that the products they manufacture are fit for purpose and make a valuable contribution to health and wellbeing.
The job of a regulatory affairs professional
It is the accountability of regulatory affairs professionals to keep abreast of the ever-changing legislation and guidelines in which their firm operates in, as they are required to give strategic advice on the legal and scientific needs that products must meet. A regulatory affairs professional will be accountable for gathering, collating, and evaluating data, as well as being responsible for registration documents and carrying out any essential negotiations that affect a product's market authorization.
Moreover, a regulatory affairs department will often be involved in the development of product marketing concepts and is commonly needed to approve packaging and advertising before a product goes to market.
Regulatory professionals play an important role and are needed in a wide number of industries, including pharmaceuticals, biopharmaceuticals, medical devices, nutrition, and cosmetics, and regulatory work is diverse in each sector. Skilled regulatory affairs candidates are in high demand, and vacancies for senior regulatory positions are easy to find, but many roles need experience, and that can be hard to get.
Qualifications to get a job in regulatory affairs
As in the initial phase of any career, your qualifications, skills, and experience all play a part in securing your first regulatory affairs job. You are expected to have a bachelor's degree in a life-sciences-related field to start your career in regulatory affairs. In some cases, you can get a position as a regulatory affairs administrator without a degree. However, this is quite a junior role, and further career progression might prove more difficult in the future.
In biotech regulatory affairs, candidates with pharmacy degrees are generally viewed more favorably than those with degrees that are less specific to drug development. Although a master's degree is not always necessary, it can be advantageous. Regulatory affairs is a constantly evolving profession that needs ongoing training. Graduates and experienced personnel alike should consider undertaking training courses such as Good Manufacturing Practice.
