Regulatory Affairs is a disciplined department that is focused on ensuring that Pharmaceutical or healthcare products, such as drugs, medical devices, treatment therapies, etc, meet the regulatory requirements before they are approved in the market for people’s use. Regulatory affairs play a vital role in ensuring the safety of pharmaceutical and other products. Each prescription medication, food and beverage you purchase has undergone rigorous regulatory checks for safety and efficacy on its path to consumers. In this article, we will discuss how you can get a job in Regulatory Affairs and other important things.

What Do Regulatory Affairs Professionals Do?

Regulatory professionals play a vital role in maintaining the safety and efficacy of food, beverages, pharmaceutical products and medical devices by ensuring appropriate licensing, legal compliance and marketing of these products. Regulatory professionals are a crucial link between the company and regulatory authorities.

Regulatory Affairs professionals work by combining their scientific, medical and legal knowledge and skills and help ensure the safe development and distribution of pharmaceutical products and make sure they meet the necessary regulatory requirements. Every new product requires a vast amount of research, time, and funds. It can take more than 10 years to develop and launch a new drug or treatment therapy in the market. Here is a list of common products that regulatory affairs professionals deal with

  • Pharmaceutical products
  • Agrochemical products
  • Cosmetics
  • Pesticides
  • Diagnostic devices
  • Medical devices
  • Therapeutic devices
  • Veterinary Medicines
  • Surgical instruments
  • Complementary Medicines

How To Start Your Career in Regulatory Affairs Jobs

There is no particular educational degree required to start a career in Regulatory Affairs. Here are some minimum educational eligibility criteria for freshers in India and abroad.

Education Required to start Regulatory Affairs Job.

  • Bachelor’s Degree in Life Sciences
  • B.Pharma or M Pharma
  • Medical degree such as: MBBS, BDS, BHMS, BAMS, BUMS, BSMS, etc
  • Bachelors in Nursing
  • Bachelors in Physiotherapy

Note: A degree in a life sciences or health-related field is usually mandatory.

Advance Qualifications

The following advanced qualifications are not mandatory but are highly preferred and advised for freshers to get a kick start to their career and get a job in Regulatory Affairs for freshers:

Note: These certifications can be helpful and increase the chances for freshers to get a job in Regulatory Affairs.

Essential Skills for Regulatory Affairs Jobs

A regulatory affairs job is not a piece of cake. It is the most crucial job role that ensures patients and consumer’s safety. Here are some skills that are required to make a good regulatory affairs professional, and learning these skills can help with gaining a regulatory affairs job in the pharma industry for freshers. Let’s take a look at some skills.

Career Paths & Job Roles in Regulatory Affairs

Regulatory affairs offers lucrative career paths that come with great career growth opportunities. Here are the following titles that regulatory affairs hold, from fresher to experienced and their average salary.

Top Companies That Hire For Regulatory Affairs Roles: Freshers And Experienced

Regulatory affairs offers promising career opportunities in various fields and at top MNCs in India and globally. Here are a few companies that hire for Regulatory Affairs jobs for freshers and experienced professionals.

Top Locations for Regulatory Jobs in India:

Cities like Hyderabad, Bangalore, Mumbai, Pune, Chennai, and Delhi, where pharma companies are heavily based.

Overview

The role of a Regulatory Affairs Specialist is not only intellectually stimulating but also carries a significant impact. By ensuring that medical products meet the necessary regulatory standards, you contribute to improving patient outcomes and the overall health of the population. But getting into regulatory affairs can be overwhelming and challenging. Institutes like CareerInPharma, India’s Best Pharma Training Institute, can help you and guide you to the right career path. 

FAQs about Jobs in Regulatory Affairs

1. Is Regulatory Affairs a good career for freshers?


 Yes absolutely. Regulatory Affairs is a growing field in the healthcare, nutrition and pharmaceutical industry with strong career growth in India and abroad, especially for candidates from life sciences and healthcare backgrounds.

2. Can I get a Regulatory Affairs job without a certification?


Certifications are not mandatory but certifications in Regulatory Affairs , Clinical Research and Pharmacovigilance significantly improve your chances of getting hired as a fresher in India and abroad.

3. What are the common interview questions in Regulatory Affairs?


 Expect common questions in regulatory affairs interviews are mainly on ICH-GCP guidelines, drug development process, regulatory submissions, documentation practices, and scenario-based compliance challenges.

4.  What is the difference between Regulatory Affairs and Pharmacovigilance?


 Regulatory Affairs mainly focuses on compliance and product approval, while Pharmacovigilance is centered on monitoring drug safety once the product is launched in the market.

5. How long does it take to build a career in Regulatory Affairs?


 With the right guidance, right education, and advance certifications, and experience, professionals can grow from entry-level roles to senior positions in 5–10 years.

Hi, Thanks for visiting my website. I am Dr Neema Bisht, Director and Co-Founder at CareerInPharma, India’s largest online training company for healthcare professionals in pharma industry. I am a dentist by degree and after working in various pharma companies at several positions, I am now on a mission to guide 1L+ healthcare professionals including doctors and life-science graduates into making amazing careers into pharma companies who are ready to hire them with various perks and benefits.