Last few years, I am engaged in teaching and working in regulatory affairs domain. I do have students from different backgrounds with industrial experience ranging from 0 years to 20 years. From the last 5 years of teaching experience at InClinition Institute, India, I found some interesting observations and case studies that professionals working in regulatory affairs domain should remember.
Meena (name changed) is one of such case. She has done B. Pharmacy from one of the reputed colleges in Mumbai and had some of the contacts in industry. She joined in regulatory affairs field by using such contacts. But life was never so easy for her. Immediately she recognized that she has to learn a lot before getting entry to this field. One colleague suggested her to join PG diploma course in regulatory affairs. After a month of research she has recognized that many of the institutes do not provide hands on experience of CTD (Common Technical Document) or dossier drafting. However, she came to know from Chinmay (name changed) about InClinition and she successfully completed a PG Diploma course in online mode with hands on CTD experience.
For people like her, some of the job essentials include
- Compilation and publishing of variety of drug product submissions
- Contribution to overall publishing strategies to ensure compliance as per regulatory requirements.
Also challenges that she is facing, include:
- Less experience
- Job demands
- Unclear development priorities
Now here comes the question in mind, what makes life of a graduate in life sciences (including Biology, Biotechnology, and Chemistry) and pharmacy easier to enter the regulatory affairs field.
First of all, it should be noted that joining immediately as fresher (even though you are MPharm or MSc), is difficult. Along with traditional degrees, you need to pursue additional education. After your degree or masters, we generally advise you to work either in production or quality control or quality assurance for at least 1-2 years so that you can get basic process knowledge. This is most essential thing as it provides you basics and working style of pharmaceutical industry. During this period, most important of all is professional involvement in the field. After this period or along with this, you can do additional learning by diploma or PG diploma to enter successfully in the field.
Second case that I came across was of Abhijit (name changed) who was working in API Research and Development at one American MNC in India. He was fed up of lab work and now after learning regulatory affairs, he is working in another MNC as regulatory affairs specialist. After 10 years of experience in API industry, he is now happy with the job. Now as he had an experience, company considered him as manager in regulatory department.
Job descriptions for him include:
- Risk benefit analysis for company’s product portfolio
- Handling of monitoring and any required post marketing surveillance and vigilance activities in compliance with regulatory requirements
Challenges that he came across:
- Travel / Family issues
- Prioritization of job tasks
- Shift from tactical to strategic role in department
However, Raghurama (who is MPharm in Pharmaceutics) was working in formulation development had chose same career path as Abhijit.
From these cases, we can understand that for the regulatory affairs jobs, at least degree with some additional learning (i.e. PG Diploma) along with minimum 1-2 years of experience is necessary.
Even though, you get the job of regulatory affairs, you now need to keep yourself updated. Here we can be of your great help. At InClinition, we organize Continuing Pharmaceutical Education (CPE) programs / seminars wherein you can keep yourself updated. Also it provides a networking platform for professionals to shift their jobs and get idea about new opportunities. For example, India will be having new regulatory body for medical devices. This will open opportunities for regulatory professionals to do their careers in medical device area along with API and formulations.
To summarize, I am suggesting new framework which can serve as a path for regulatory professionals.
- Evaluate your level of knowledge in regulatory affairs
- Assess strengths and weaknesses
- Estimate amount of time available
- Estimate ability, and knowledge acquisition time for growth
- Pen it down SMART (SMART – Specific, measurable, achievable, realistic and timely) objectives
- Identify opportunities for the same
- Acquire advanced level of knowledge
- Stay engaged … Learn, Learn and Learn
Also resources for regulatory professionals include,
- Membership of professional associations
- Attending Continuing Education Programs (CPE)
- Additional educational certifications or PG Diplomas
- Joining Learner’s Community (e.g. Webinars, E-learning courses)
- Job search and developing skills related to it
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