Biotecnika Webinar on World Regulatory Affairs: Exploring Profession Paths and Future Scope
Date: fifth April 2025 (Saturday)
Time: 7:00 PM IST
Period: 1 Hour
Mode: On-line
Organized by: BioTecNika
Audio system: Prakash B & Shweta Birajdar
BioTecNika efficiently hosted an insightful webinar on World Regulatory Affairs – Profession and Future Scope on fifth April 2025, bringing collectively business specialists and aspiring professionals to delve into probably the most pivotal domains in prescription drugs and scientific information administration. The session was led by two distinguished specialists: Prakash B, a Senior Regulatory Affairs Skilled with over 10 years of expertise in international pharmaceutical markets, and Shweta Birajdar, a Medical Knowledge Administration Scientist at BioTecNika, with a robust background in regulatory affairs, scientific information administration, and drug security.
The webinar started by highlighting the pivotal function regulatory affairs play in making certain drug security, compliance, and finally, the safety of public well being. Regulatory professionals function a bridge between departments similar to R&D, manufacturing, and advertising and marketing to make sure that merchandise meet each nationwide and worldwide requirements. They’re chargeable for monitoring regulatory adjustments, making ready submission paperwork, and sustaining compliance all through a product’s lifecycle.
A good portion of the dialogue targeted on how regulatory affairs professionals
contribute to labeling, post-marketing surveillance, and Good Manufacturing Observe (GMP) compliance. Emphasis was positioned on partaking early with international well being authorities just like the EMA and FDA to streamline the approval course of and keep away from delays throughout drug improvement.
An thrilling facet of the session was the evolving panorama of regulatory affairs with the mixing of digital well being applied sciences and synthetic intelligence. From telemedicine and wearables to AI-driven diagnostics, know-how is reshaping the way in which regulatory professionals function. Nevertheless, moral considerations similar to information integrity, privateness, and compliance had been additionally highlighted as areas requiring cautious navigation. Regardless of AI’s rising function, each audio system emphasised that it’ll help reasonably than exchange human experience.
On the profession entrance, the webinar make clear the growing demand for expert regulatory affairs professionals, particularly these with life sciences, pharmacy, or biotechnology backgrounds. Academic establishments like JSSUT and platforms similar to BiotecNika at the moment are providing specialised packages to fulfill this rising want. Entry-level job roles embrace regulatory coordinator, compliance analyst, doc reviewer, and labeling specialist, with aggressive salaries and robust profession progress potential.
Famend specialists headlined the webinar session:
Prakash B
Senior Skilled in Regulatory Affairs
Prakash B highlighted the very important function of regulatory affairs (RA) in making certain drug security and compliance. He defined how RA professionals act as a bridge between pharmaceutical firms and international well being authorities, dealing with submissions, lifecycle administration, and compliance with altering rules. He careworn the necessity for early engagement with companies just like the FDA and EMA and spoke concerning the growing demand for RA professionals, particularly with rising instructional alternatives in India. He additionally touched on the way forward for RA, emphasizing digital well being, AI integration, and the evolving scope of the sphere.
Shweta Birajdar
Regulatory Affairs & Medical Knowledge Administration Scientist, BioTecNika
Shweta Birajdar targeted on the connection between scientific information administration and regulatory affairs. She shared her expertise main RA groups, making certain compliance, and sustaining information high quality. She mentioned how AI is bettering doc overview and compliance processes, whereas additionally elevating moral and information safety considerations. Shweta inspired professionals to construct expertise in regulatory writing and GCP compliance, and suggested networking and steady studying to reach the evolving regulatory panorama.
Key Highlights of the Webinar:
- Position of Regulatory Affairs: From aligning R&D, manufacturing, and advertising and marketing groups to making sure drug security and efficacy, regulatory professionals are central to pharmaceutical success.
- Strategic Tasks: Professionals handle compliance paperwork, oversee labeling, observe international regulatory adjustments, and work together with well being authorities like EMA and FDA.
- Profession Alternatives: Numerous job roles similar to regulatory coordinators, compliance analysts, and doc controllers provide aggressive salaries and rising demand throughout India and overseas.
- Training & Upskilling: The rise of specialised programs in Indian establishments (like JSSUT) and internship/coaching packages from BioTecNika had been emphasised as recreation changers for biotechnology graduates.
- AI in Regulatory Affairs: The webinar make clear how synthetic intelligence is reworking doc dealing with, threat evaluation, and digital well being regulation, whereas additionally elevating moral and information high quality considerations.
- World Traits & Digitalization: Future tendencies embrace longer drug improvement timelines and larger involvement of regulatory specialists from early improvement phases by way of post-approval phases.
- Networking & Mentoring: Individuals had been inspired to attach with professionals on LinkedIn and search steering from business mentors like Prakash and Shweta for profession development.
In regards to the Audio system:
Prakash B
Senior Skilled in Regulatory Affairs
With over a decade of expertise in international regulatory affairs, Prakash B is a seasoned skilled in pharmaceutical improvement and compliance. He focuses on managing regulatory submissions, lifecycle methods, and sustaining market authorization for international markets. His experience lies in coordinating with companies just like the FDA and EMA, making certain regulatory compliance throughout all phases of drug improvement. Obsessed with training, Prakash emphasised the rising significance of regulatory affairs as a profession path and inspired college students from life sciences backgrounds to discover diploma programs and certifications to reinforce employability on this high-demand sector.
Watch Biotecnika Webinar on World Regulatory Affairs Beneath
Shweta Birajdar
Regulatory Affairs & Medical Knowledge Administration Scientist, BioTecNika
Shweta Birajdar is a scientific information administration knowledgeable with vital expertise at prime organizations together with TCS, Aston Carter, and EVERSANA. With a robust background in GCP compliance, regulatory reporting, and staff management, she has managed regulatory operations and ensured audit readiness throughout international markets. Shweta has performed an important function in mentoring scientific analysis professionals and optimizing scientific trial techniques. On this webinar, she make clear the intersection of AI, digital well being, and regulatory affairs, whereas providing precious steering on profession progress, upskilling, and the significance of networking within the regulatory area.
About BioTecNika
With 18+ years of experience, BioTecNika is India’s No.1 biosciences platform, connecting 4.5M+ professionals worldwide. We concentrate on training, recruitment, and expertise improvement for the biotech and pharma industries, serving to people and organizations keep forward within the ever-evolving world of life sciences. At BioTecNika, we’re dedicated to empowering careers, fostering innovation, and shaping the way forward for biosciences.
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