• What does the word ‘Regulatory’ mean to you?

All consumer products (Pharmaceutical products, veterinary medicines, medical devices, and food supplements), that are subjected to certain protocols designed by government to protect public health falls under the purview of regulatory framework. The Regulatory Sciences vertical ensures that their companies comply with all of the regulations and laws concerning their business.

• What is the role of ‘Regulatory Department’ in pharma/biopharma companies?

The Regulatory Affairs department is an important part of the organisational structure of pharmaceutical companies. Internally it liaises at the inter-phase of the life cycle of the drug and externally it is the key interface between the company and the regulatory authorities.

• What made you choose Regulatory as your career?

Primary reason for choosing Regulatory is the potential for growth and upward mobility and the ability to make an impact. The thought of being able to contribute to the approval process of a drug is very challenging but extremely gratifying and a matter of pride.

• What measure you take to avoid any mistakes during regulatory documentation?

“If it is not written down, then it didn’t happen”- is the thumb rule I follow in order to avoid any sort of discrepancies.

• What challenges you face, as a regulatory professional?

Keeping oneself updated with the international and regional regulations & guidelines and equipping the CFTs to be streamlined with the same. It is the responsibility of RA to keep abreast of current legislation, guidelines and other regulatory intelligence.

• How do you manage the process of working with project teams within the company and interacting with the regulatory health agencies?

Regulatory Sciences team do regular correspondences with the regulatory health agencies right from the drug development phase to the registration of the product. The project teams are kept in loop with the communications with the regulatory health agencies up to date and making sure the project is running as per the timeline.

• How is Indian Regulatory Framework different from that of International Regulatory framework?

India is substantially on track to meet global standards of pharma regulatory framework. Europe has been way ahead of the other countries including US in terms of developing biosimilars. Regulatory requirements for the approval of products are similar but slightly different in the scope of the guidelines, the choice of the reference product, and the data required for product approval.. The Indian government has taken several initiatives towards streamlining the way pharmaceuticals will be regulated in our country. These steps would ensure more affordable drugs being manufactured and made available to patients both in domestic and export markets.

• What challenges according to you a pharma company faces during registration and approval of the drug?

Drug development is a lengthy, complex, and costly process, entrenched with a high degree of uncertainty. The success of the approval, typically for generic complex products lies on understanding the Agency’s expectation of the studies required to establish the sameness with the innovator and right interpretation of the guidance available.

• Why is it necessary for the Regulatory affair department to follow-up with each step of the drug development process?

Generic drug product development uses a different approach and strategy compared to that used to develop an innovator drug product.

Generic drug product manufacturers must formulate a drug product that will have the same therapeutic efficacy, safety, and performance characteristics as of its branded counterpart. The key factor is that the generic drug product must meet all the necessary criteria to be therapeutically equivalent to the innovator. RA does the regulatory intelligence mining required and ensures that, each step of the development is as per the requirement, keeping the “end in mind”.

• What are the main documents & applications that a Biopharma company need to maintain?

Documentation in a biopharma company is the key to GMP compliance and ensures traceability of all development, manufacturing, and testing activities. Hence, the documents pertaining to all these facets has to be well archived and maintained.  Documentation provides the route for auditors to assess the overall quality of operations within a company and the product

• How do you think these Functional Visits and sessions with SMEs as part of Biosciences Program help students make a career in Pharma Industry?

Biocon Academy has consistently proved to be a brilliant platform to bridge the gap between academics and industry applications and help cover the deficits. SMEs play an exceptional role in delivering the same and getting the students industry ready.

• What is your key takeaway as an SME till now?

Interacting with different students from different backgrounds is a very enthralling experience and gives a boost and responsibility to keep oneself up to date with the technology and regulations.

• How many sessions you take with the students? How do you ensure your learnings are delivered well to the students?

I take two sessions per month, for each team of students, which goes up depending on the schedule. I tend to keep the class interactive and practice lot of QnAs, to make sure, whatever is imparted to them has been received well.

• Lastly, one advice for the students who seek their careers in Regulatory Affairs/IRA?

Regulatory Science is an exceptional vertical, where there is a lot of scope to do front ending and one is always involved in all phases of the drug development process. It’s a very challenging but gratifying role to play.

SME Profile:

Sweety Mathew is a part of International Regulatory Affairs team in Biocon and a Subject Matter Expert (SME) for Biocon KGI Program in Biosciences.

Ms Sweety Mathew, Executive – Regulatory Affairs, Biocon