Launch Your Regulatory Affairs Career Worldwide Skills, Certifications & Industry Insights
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Launch Your Regulatory Affairs Career Worldwide: Skills, Exams & Industry Insight

An Exclusive Webinar that Empowered Aspirants with Essential Skills, Global Certifications, and Insider Insights to Launch a Regulatory Affairs Career Worldwide.

  • Date: 12th August 2025
  • Time: 7:00 PM – 8:00 PM IST
  • Location: Bengaluru, Karnataka (Online)

Biotecnika successfully conducted the much-anticipated online webinar, “Launch Your Regulatory Affairs Career Worldwide: Skills, Certifications & Industry Insights”, an intensive, knowledge-packed session that brought together aspiring Regulatory professionals, students, and working experts eager to explore global career opportunities and learn how to build a Regulatory Affairs Career Worldwide in the rapidly expanding domain of Regulatory Affairs (RA).

The one-hour event was strategically designed to deliver a comprehensive roadmap for anyone aiming to enter or advance in the field of RA, covering in-demand technical and soft skills, globally recognized certifications, career strategies, and the latest industry hiring trends. It also marked the official launch of Biotecnika’s Global Regulatory Affairs (GRA) Course, a specialized program customized to bridge the skill gap between academic knowledge and Industry expectations.

Setting the Stage – Welcome & Introduction

The session commenced with Dr. Tanushree Saxena, who warmly welcomed the attendees and introduced the significance of Regulatory Affairs in today’s global Life Sciences landscape. She outlined how RA professionals serve as vital connectors between product development and market authorization, ensuring Compliance with evolving Regulatory requirements while safeguarding public health.

She also introduced the distinguished panel of speakers, each with remarkable credentials and rich, real-world experience in RA, Clinical Research, Quality Assurance, and Industry operations.

01 Essential Skills for a Global Regulatory Affairs Career

Speaker: Mrs. Bhanu Melvin – Academic & Research Support Specialist – CDM, PV & RA, Biotecnika

Mrs. Bhanu Melvin brought over a decade of multidisciplinary expertise spanning Pharmacy, Academia, Healthcare, Regulatory Affairs, and corporate training. Having successfully trained more than 1,500 individuals, ranging from academic aspirants to working professionals, in Clinical Research, Pharmacovigilance, Clinical Data Management, Regulatory Affairs, and Clinical SAS programming, she offered a uniquely holistic perspective.

Her globally recognized certifications in Pharmacovigilance, Lean Six Sigma Black Belt, Clinical Research, Clinical SAS Programming, and ISO 9001:2015 Lead Auditing have empowered her to design skill-focused curricula, improve Compliance standards, and streamline Clinical workflows.

She explained:

  • Core Technical Skills: Proficiency in Regulatory Documentation, Dossier preparation, and Compliance protocols.
  • Key Soft Skills: Strong communication, meticulous attention to detail, and effective project management.
  • Global Regulatory Knowledge: Familiarity with agencies such as the US FDA, EMA, MHRA, PMDA, and TGA, along with their respective Regulatory frameworks.
  • Digital Competence: Use of Regulatory intelligence platforms and document management tools to streamline submissions and maintain Compliance.

Mrs. Melvin emphasized that aspiring RA professionals must combine Technical expertise with adaptability, continuous learning, and the ability to collaborate across cross-functional teams to succeed in building a Regulatory Affairs Career Worldwide.

02 Certifications & Exams to Boost Your Global Employability

Speaker: Mr. Chirag Panchal, Manager – Regulatory Affairs (CMC Expert), Amneal Pharma

Mr. Chirag Panchal, an experienced Regulatory Affairs Specialist with extensive experience in Dossier submissions, Compliance strategies, and global market registrations, shared his career journey, which spans Amneal Pharma, Novartis, Cipla, and Gufic Biosciences.

His presentation provided attendees with a practical blueprint for enhancing employability through certifications, including:

  • Recognized Certifications: Regulatory Affairs Certification (RAC – US, EU, Global), regional Licensing exams, and short-term credentials from reputed institutions.
  • Eligibility & Exam Preparation: Guidance on understanding exam structures, choosing relevant certifications based on career goals, and managing preparation schedules alongside work commitments.
  • Balancing Theory & Practice: Strategies to combine certification studies with real-world experience through internships or on-the-job learning.
  • Industry Entry Points: Targeting internships and roles in Contract Research Organizations (CROs), Pharmaceutical companies, and Regulatory Consultancies.

Drawing from his professional milestones, Mr. Panchal also highlighted tools such as Trackwise, Documentum, and EXTEDO that modern RA professionals should master for effective Dossier management and submissions.

03 Industry Insights & Career Launch Strategies

Speaker: Dr. Ganeshan, Ph.D. in Microbiology, Scientific Expert – QA/QC & Global Regulatory Affairs, Biotecnika

Dr. Ganeshan, whose career has spanned Biosimilars, Quality Assurance, Medical Diagnostics, and Medical Devices, captivated attendees with her wealth of knowledge in both Technical and Strategic aspects of RA. As the former Clinical Director at Medical Electronic Systems India Pvt. Ltd., she led the development of an advanced Diagnostic testing kit for semen analysis, underscoring her commitment to innovative, impactful solutions.

Her expertise encompasses Clinical Trials, Data Analysis, and Regulatory Compliance, complemented by a passion for teaching and making complex Scientific concepts relatable.

She explored:

  • Global Hiring Trends: The surge in demand for RA professionals in the Pharma, Biotech, and Medical Device sectors.
  • Sectors with Opportunities: From large multinationals to niche consultancies.
  • Entry-Level Pathways: Internships, trainee positions, and freelance Regulatory writing as stepping stones.
  • Career Growth & Mobility: How RA roles can pave the way for international career opportunities.
  • Resume & Interview Preparation: Tips for Crafting a Global-Ready CV and cracking Technical Interviews.
  • Networking & Professional Development: Leveraging associations like RAPS, DIA, and local Regulatory bodies for mentorship and career visibility.

She concluded by sharing how Biotecnika’s GRA Course could serve as a launchpad for aspiring professionals, offering both knowledge depth and practical exposure.

Interactive Q&A and Closing Remarks

The webinar concluded with a lively Q&A session, where attendees sought advice on career transitions, certification timelines, and country-specific regulations. Dr. Tanushree concluded the webinar by thanking the expert speakers and participants, sharing additional resources, and encouraging attendees to take actionable steps toward their RA careers.

Key Takeaways for Attendees

The session offered actionable, real-world guidance, including:

  • A clear understanding of the global RA landscape and its evolving challenges.

  • Insights into essential skills, both technical and interpersonal, required for success.

  • A roadmap to selecting the right certifications for international employability and positioning yourself for a thriving Regulatory Affairs Career Worldwide.

  • Proven strategies for breaking into the industry through internships, networking, and skill development.

  • Knowledge of digital tools and platforms used in RA workflows.

  • Inspiration from industry veterans who have navigated and excelled in the field.

Global Regulatory Affairs Hands-on Training Program – Admissions Open!

Batch Starts – 21st August 2025

CLICK HERE TO CHAT WITH A GRA EXPERT 

CLICK HERE TO ENROL

About BioTecNika

BioTecNika is India’s leading platform for Life Sciences education, training, and career advancement. For over a decade, the organization has empowered students, researchers, and professionals with innovative courses, competitive exam coaching, and industry-aligned skill development programs. With a vision to bridge the gap between Academia and Industry, BioTecNika delivers innovative learning experiences designed to help aspirants achieve their academic and career goals.

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