Being a quality-focused and responsible pharmaceutical company we ensure that our products comply with the regulatory requirements of the different countries that we do business in. We wanted to know the nitty-gritties of approval processes and hence we decided to have a meet up with Ms. Mona Gogia, Assistant Vice President (AVP), Regulatory Affairs to understand the importance and role played by regulatory affairs team.
As we entered her cabin, we were greeted with a big smile. On knowing that this discussion would be part of our ‘Women Leadership at Cadila’ series, Ms. Gogia was happy to be a part of this journey.
Q- What exactly is the role of a regulatory affairs (RA) department?
“Since we are in the business of manufacturing medicinal products, obtaining approvals from the regulatory authorities of the countries where we wish to market our products, is an important aspect of the organization. Our job is to get these Marketing Authorisations for our products in countries that we operate in.
The whole process of obtaining approvals for the products is quite a meticulous one. Each country has its own regulatory environment. In general, we need to submit product related information to the country specific regulatory authority. This information is then reviewed by the authorities to determine whether the product is safe and effective, and is manufactured as per the current Good Manufacturing Practices. Only then Marketing Authorization is granted for distribution of the product in the country. Our product range includes finished pharmaceutical drug products and drug substances, herbals, biologicals and vaccines.
Being an innovation driven company, we are also involved in conducting clinical trials for new drugs. Regulatory Affairs is responsible for obtaining necessary approvals to conduct clinical trials for our innovative products. We also ensure that all our factories follow the factory regulations issued by local authorities and are running under a valid manufacturing licence which needs to be renewed every 5 years.
Q- What attracted you to regulatory affairs?
I began my career as a formulation research scientist and spent six years developing patent non-infringing formulations for US and Europe market. Getting the products approved in European countries came as an additional responsibility in one of my previous companies, seventeen years ago. I found myself perfectly aligned with the job role of a regulatory professional and have not looked back since then. I have been in the industry for 23 years now with experience in getting product approvals across the globe.
Q- What do you like the best about your job?
Adopting to the changing regulatory environment, application of analytical skills and scientific expertise, continuous learning, interaction with people from different technical areas internally as well as outside the company, representing the company in various forums are some of the highlights of my job.
Q- What are some of the exciting projects that you are working?
Cadila’s vision is to create affordable and quality medicines for all. An important part of this journey is innovation. Currently, we are working on new projects with our collaborators for new product development which is enthralling. We also have a vaccine pipeline under development which again is very challenging but opens up new avenues for us.
Q- What are your favourite things about Cadila?
The legacy of the company, the journey of building an empire from scratch, the difficult path that our founders had to traverse to create and grow this company, inspires me.
The working culture is also a huge motivating factor. There is an ecosystem out here which encourages learning. The experience here enriches an individual’s skill set and helps them emerge as mature professionals.
Q- What are some of the qualities you look for in a team?
One should be technically sound, have foresight in the relevant area and have an eye for detail; good communication skills (a crucial skill in the regulatory environment); hard-work, positive attitude and leadership skills are some qualities that I look for in my team members.
Q- How do you like to unwind after work?
I am fond of reading fiction. Many a times, I can find myself reading 2 books concurrently. At least 2 annual vacations with my family is something I look forward to. I am also enthusiastic about ancient architecture and nature and wish to visit all places in India that are known for their marvelous ancient architecture.
Q- How do you feel as a woman leader in the industry?
I recently read an article in the newspaper saying that out of the total women working in technical areas in India, only 11% are in senior leadership roles. There is a need to improve these statistics and this can be done by creating an ecosystem that encourages recruitment of women and growth of their career. Women have a large role to play in their families and hence maintaining a work-life balance becomes important. The working environment must be empathetic to such needs of women. Further, disparity still manifests itself in various ways in all industries. This contributes to the overall low percentage of women across industries. So, I feel blessed to have been a part of the industry for the past 23 years and enjoy each day of my work.
Q- Do you want to give any message to your fellow women leaders?
I would like to come back to the same article. If only 11% of the total women in technical areas are in the senior leadership role, we need to create more women leaders. Encourage and build an ecosystem that creates more women leaders. Create more women workforce in general. It not only helps the women in their own social-economic development but also contributes to the economic development of the country. Last but not the least, spread sisterhood and encourage women to maintain mental, physical and emotional well-being for an overall healthy society.