Career In Regulatory Affairs – Job Opportunities, Eligibility & Skills Required

Regulatory Affairs Career – Job Opportunities, Eligibility & Skills Required

What is Regulatory Affairs?

Regulatory affairs is a profession within regulated industries such as pharmaceuticals, biopharmaceuticals, medical devices, cosmetics and consumer health, natural health, and veterinary products. Regulatory affairs is a department within the company that interacts with the government authorities who regulate the activities of the company. Their aim is to protect public health in terms of safety, quality, and efficacy of products like medical devices, pharmaceuticals, veterinary medicines, pesticides, cosmetics & complementary medicines, agrochemicals, etc. These professionals keep a check on how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed in order to ensure that the products being supplied are safer for public health-wise as well as in providing a profitable contribution to the welfare of the public.

Although regulatory affairs specialists work in a wide variety of disciplines such as public policy, health, science, economics, and law but the majority of them work in industries such as biotechnology, food science, pharmaceutical as well as medical device sectors. Few others work as consultants in marketing, research, or law entities in their Regulatory Affairs Career. Some are also employed by healthcare, clinical research organizations, and

Regulatory Affairs Career is a profession within the healthcare industry namely, pharmaceutical, healthcare, medical device, biologics, and functional food. It forms a bridge between drug regulatory authority, the pharmaceutical industry, regulatory affairs professionals. It is a centralized department for communication of registrations, queries associated with a product in FDA as well as the ministry of health of various countries.

Main objectives in Regulatory Affairs Job Profile includes:

• Keeping track of changing legislation in regions where the company distributes its products.
• Interpret and apply regulations.
• Advise internal colleagues on legal and scientific requirements.
• Develop and implement regulatory strategies.
• Collect, collate and evaluate scientific data.
• Participate in product development programs to ensure adherence to international regulations and guidelines.
• To give strategic and technical advice to R&D, production, QC department, etc right from the beginning of the development of the product, making an important contribution both commercially and scientifically to the success of a development program and a company as a whole.
• Prepare submissions to regulatory agencies such as Health Canada, EMA(Europe) and other jurisdictions.
• Helping the company in order to avoid problems that may be caused due to improper scientific thinking or due to poor presentation of data.

Regulatory Affairs professionals interact with numerous functional areas which include:

• Pre-clinical research : Pharmacology and toxicology testing to evaluate new drug candidates.
• Clinical Research: Conduct of clinical studies, data collection, statistical analysis, report writing
• Manufacturing: High levels of controls for the production of safe and efficacious products.
• Quality control: Analytical testing of all products in terms of purity, safety, potency, and quality.
• Quality assurance: Oversight of operations related to failure investigations, auditing, complaints and documentation management.

Qualifications Required To Become A Regulatory Affairs Professional / To Make Career in Regulatory Affairs:

• A Bachelor’s degree in the field of science especially pharmacy, biology, pharmacology, microbiology, biochemistry is a must for getting into as RA.
• For junior positions, undergraduates or postgraduates is sufficient but for senior positions
• In the field of clinical research, it is mandatory for a person to have a doctorate degree.
• In order to get very good success in this field one must start his/her career with a related field like for example, laboratory testing, production, quality control, quality assurance, etc. with this he/she will get a good practical experience in drug development and its related process.
• However, professionals with essential skills in biology, clinical sciences, management, engineering, and writing are also highly desired candidates for this diverse field.

Additional Skills required for Regulatory Affairs Career:

• Good analytical skills so that they can pay close attention to all the details review process and data and identify the issues if any.
• Good negotiating skills
• Judgment skills and presentation skills
• Good communication skills since they need to interact with clients, staff members and other regulatory authorities.
• Good computer skills, since certain tasks like preparation of reports and analysis of data, are done with the help of a computer.
• Project management skills are of utmost importance since one has to do different types of work and time also less so they must know how to shuffle multiple tasks efficiently.
• Ability to keep up to date on current regulations

Regulatory Affairs employment opportunities exist in the following sectors:

Pharmaceuticals : The newly graduated Pharmacist have the best opportunity to start their careers as regulatory professionals in regulatory affairs department of a pharmaceutical industry. The function of Regulatory Professionals in Pharma industry is to provide all legal information like updates in amendments in the law, new drug inventions and drug development designs, patent, trademark, and copyrights. Information about Biological and Pharmaceutical drugs and guidance regarding rules and regulation of drugs, latest good manufacturing practices, science and Technology updates and their regulatory aspects, post-marketing surveillance of the product to compile the documentation of pharma industry.

It is a rapidly growing department of pharma industry because most of the stakeholders are now interested in the export of their pharmaceutical products in other countries but international markets demand strict regulation and legal requirements in terms of allowing marketing authorization of pharmaceutical products. Internationally many countries require pharmaceutical Dossier or Common Technical Document(CTD) format for registration of the drugs or marketing authorization of the products. CTD is the set of documents ensuring quality, safety, and efficacy of the pharmaceutical or biological products which should be prepared according to the requirements of regulations prescribed by the governing authority of India.

Medical devices: The medical device industry plays a critical role in the department of healthcare by providing ingenious solutions that will improve the patient end result. RA professional in the field of medical serves a very important role in the lifecycle of the product like for eg: he/she can advise the team regarding regulatory strategies in order to ensure that the product is legally marketed. Once the design of the product is complete the team of product development experts RA to make a successful marketing submission. And finally, these companies will rely on them for post-marketing surveillance in order to confirm it to FDA if any malfunctioning them.

Biotechnology companies: Biotechnology and Regulatory affairs are the areas that are creating opportunities for us to build networks across the world and to work collaboratively together. Depending upon the individual’s experience one can make a good career here.

Biological products need to be readdressed by means of scientific advances and it is needed to put a hold in the initiation of new quality control procedures without sufficient discussion. There is a growing demand for preclinical testing of Biotechnological products. With the development of Biotechnological industries, it has catalyzed various changes in the regulation of drugs worldwide with major blow on the regulation of unnatural products.

Clinical research: In the field of clinical research Regulatory Affairs Professional has a vital role in making safe and good quality products related to healthcare. Their responsibility begins with the research and development phases of each product. They keep themselves updated in terms of procedures, regulatory policies, and trends. One can enter as a clinical research coordinator or Drug Safety Associate at their entry-level. In their mid-level, they can enter as a Clinical Research Associate or Investigator. And at the senior level, they can be appointed as a Data Manager, Director of Regulatory Affairs.

Top Companies Hiring For Regulatory Affair Jobs are:

• ITC
• Parexel
• Medtronic
• Novartis
• Novozymes
• IQVIA
• Bharat Serums and Vaccines Ltd
• Amgen
• Reckitt Benckiser
• Jhonson & Jhonson
• Lupin
• PPD
• Apotex
• Dupont
• Genpact
• Merck
• Covance

Regulatory Affairs is ever-changing legislation thus one can always keep on learning new things and keep on taking up new challenges and at the same time, you will have a good salary package. A career in Regulatory affairs is one of the versatile professions one can ever come across because it provides diversified employment opportunities that too at various levels.

Even though Regulatory Affairs is one of the most interesting and rewarding careers but still it has its own challenges. So there are a lot of things to be considered when you think of Regulatory Affairs as a Career. You need to evaluate the goals both personally as well as professionally in order to have a better understanding of how our career can meet your goals.

About the Author

Divya is a CSIR NET Topper with an educational background in Biotechnology. She is one of the finest teachers at Biotecnika and wins a student’s heart with her immense knowledge and experience. Ms. Divya believes in self-motivation and also tries to boost up her students.