Biotecnika Webinar on Global Regulatory Affairs: Exploring Career Paths and Future Scope
Date: 5th April 2025 (Saturday)
Time: 7:00 PM IST
Duration: 1 Hour
Mode: Online
Organized by: BioTecNika
Speakers: Prakash B & Shweta Birajdar
BioTecNika successfully hosted an insightful webinar on Global Regulatory Affairs – Career and Future Scope on 5th April 2025, bringing together industry experts and aspiring professionals to delve into one of the most pivotal domains in pharmaceuticals and clinical data management. The session was led by two distinguished experts: Prakash B, a Senior Regulatory Affairs Expert with over 10 years of experience in global pharmaceutical markets, and Shweta Birajdar, a Clinical Data Management Scientist at BioTecNika, with a strong background in regulatory affairs, clinical data management, and drug safety.
The webinar began by highlighting the pivotal role regulatory affairs play in ensuring drug safety, compliance, and ultimately, the protection of public health. Regulatory professionals serve as a bridge between departments such as R&D, manufacturing, and marketing to ensure that products meet both national and international standards. They are responsible for tracking regulatory changes, preparing submission documents, and maintaining compliance throughout a product’s lifecycle.
A significant portion of the discussion focused on how regulatory affairs professionals contribute to labeling, post-marketing surveillance, and Good Manufacturing Practice (GMP) compliance. Emphasis was placed on engaging early with global health authorities like the EMA and FDA to streamline the approval process and avoid delays during drug development.
An exciting aspect of the session was the evolving landscape of regulatory affairs with the integration of digital health technologies and artificial intelligence. From telemedicine and wearables to AI-driven diagnostics, technology is reshaping the way regulatory professionals operate. However, ethical concerns such as data integrity, privacy, and compliance were also highlighted as areas requiring careful navigation. Despite AI’s growing role, both speakers emphasized that it will support rather than replace human expertise.
On the career front, the webinar shed light on the increasing demand for skilled regulatory affairs professionals, especially those with life sciences, pharmacy, or biotechnology backgrounds. Educational institutions like JSSUT and platforms such as BiotecNika are now offering specialized programs to meet this growing need. Entry-level job roles include regulatory coordinator, compliance analyst, document reviewer, and labeling specialist, with competitive salaries and strong career growth potential.
Renowned experts headlined the webinar session:
Prakash B
Senior Expert in Regulatory Affairs
Prakash B highlighted the vital role of regulatory affairs (RA) in ensuring drug safety and compliance. He explained how RA professionals act as a bridge between pharmaceutical companies and global health authorities, handling submissions, lifecycle management, and compliance with changing regulations. He stressed the need for early engagement with agencies like the FDA and EMA and spoke about the increasing demand for RA professionals, especially with growing educational opportunities in India. He also touched on the future of RA, emphasizing digital health, AI integration, and the evolving scope of the field.
Shweta Birajdar
Regulatory Affairs & Clinical Data Management Scientist, BioTecNika
Shweta Birajdar focused on the connection between clinical data management and regulatory affairs. She shared her experience leading RA teams, ensuring compliance, and maintaining data quality. She discussed how AI is improving document review and compliance processes, while also raising ethical and data security concerns. Shweta encouraged professionals to build skills in regulatory writing and GCP compliance, and advised networking and continuous learning to succeed in the evolving regulatory landscape.
Key Highlights of the Webinar:
- Role of Regulatory Affairs: From aligning R&D, manufacturing, and marketing teams to ensuring drug safety and efficacy, regulatory professionals are central to pharmaceutical success.
- Strategic Responsibilities: Professionals manage compliance documents, oversee labeling, track global regulatory changes, and interact with health authorities like EMA and FDA.
- Career Opportunities: Diverse job roles such as regulatory coordinators, compliance analysts, and document controllers offer competitive salaries and growing demand across India and abroad.
- Education & Upskilling: The rise of specialized courses in Indian institutions (like JSSUT) and internship/training programs from BioTecNika were emphasized as game changers for biotechnology graduates.
- AI in Regulatory Affairs: The webinar shed light on how artificial intelligence is transforming document handling, risk assessment, and digital health regulation, while also raising ethical and data quality concerns.
- Global Trends & Digitalization: Future trends include longer drug development timelines and greater involvement of regulatory experts from early development stages through post-approval phases.
- Networking & Mentoring: Participants were encouraged to connect with professionals on LinkedIn and seek guidance from industry mentors like Prakash and Shweta for career advancement.
About the Speakers:
Prakash B
Senior Expert in Regulatory Affairs
With over a decade of experience in global regulatory affairs, Prakash B is a seasoned professional in pharmaceutical development and compliance. He specializes in managing regulatory submissions, lifecycle strategies, and maintaining market authorization for global markets. His expertise lies in coordinating with agencies like the FDA and EMA, ensuring regulatory compliance across all phases of drug development. Passionate about education, Prakash emphasized the rising importance of regulatory affairs as a career path and encouraged students from life sciences backgrounds to explore diploma courses and certifications to enhance employability in this high-demand sector.
Watch Biotecnika Webinar on Global Regulatory Affairs Below
Shweta Birajdar
Regulatory Affairs & Clinical Data Management Scientist, BioTecNika
Shweta Birajdar is a clinical data management expert with significant experience at top organizations including TCS, Aston Carter, and EVERSANA. With a strong background in GCP compliance, regulatory reporting, and team leadership, she has managed regulatory operations and ensured audit readiness across global markets. Shweta has played a crucial role in mentoring clinical research professionals and optimizing clinical trial systems. In this webinar, she shed light on the intersection of AI, digital health, and regulatory affairs, while offering valuable guidance on career growth, upskilling, and the importance of networking in the regulatory domain.
About BioTecNika
With 18+ years of expertise, BioTecNika is India’s No.1 biosciences platform, connecting 4.5M+ professionals worldwide. We specialize in education, recruitment, and talent development for the biotech and pharma industries, helping individuals and organizations stay ahead in the ever-evolving world of life sciences. At BioTecNika, we are committed to empowering careers, fostering innovation, and shaping the future of biosciences.
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