Advance your pharma career with Biocon Academy’s 16-week Certificate Program in Global Regulatory Affairs. Batch 5 admissions open—ideal for regulatory affairs courses in India and biosciences certifications.
About the Institutions
Biocon Academy, an initiative of Biocon—a leading global biopharmaceutical company—partners with JSS Academy of Higher Education & Research (AHER), a NAAC A+-accredited deemed university in Mysuru. This collaboration delivers industry-aligned education that bridges academia and biopharma.
Biocon Academy focuses on enhancing employability through innovative programs, while JSS AHER brings academic excellence and renowned faculty. Together, they offer cutting-edge training in regulatory affairs, preparing students for global pharma roles with hands-on expertise and merit-based scholarships.
Program Details
- Program Name: Biocon JSS AHER Certificate Program in Global Regulatory Affairs (Batch 5)
- Duration: 16 weeks (full-time, intensive)
- Mode of Delivery: Classroom sessions, hands-on training, case studies, industry visits, and employee shadowing
- Program Fee: Student share: INR 1,00,000 + 18% GST
- Scholarships: Biocon Merit Scholarship covering 60%-75% of program cost for all selected students
- Location: Training at Biocon facilities (Bengaluru) and partner sites including JSS Hospital (Mysuru), CDSCO (New Delhi), and others
- Certification: Joint certificate from Biocon Academy and JSS AHER
Program Description
This one-of-its-kind certificate program in India equips aspiring regulatory professionals with comprehensive knowledge of global regulatory practices. Delivered by expert faculty from JSS AHER and Biocon’s Regulatory Science team, it combines theoretical learning with practical exposure.
Students gain insights into drug development, documentation, submissions, and compliance across regulated and emerging markets. The curriculum emphasizes experiential learning through case studies, e-CTD filings, pharmacovigilance reports, and site visits, ensuring graduates are job-ready for the dynamic biopharma industry.
Curriculum Highlights
- Introductory Regulatory Affairs: Overview of pharmaceutical markets, GMP/GLP, Intellectual Property Rights
- Small Molecule Regulatory Affairs: Regulations in USA, EU, Japan, India, ASPAC, LATAM, Africa, and Middle East markets
- Large Molecule (Biologics) Regulatory Affairs: Guidelines for USA, EU, and India
- Clinical Regulatory Affairs: Drug development process, ICH guidelines, US-FDA guidance
- Medical Devices Regulatory Affairs: Classification, lifecycle, IMDRF/GHTF, ethics, quality standards
- Documentation & Approvals: Dossier preparation, audits, inspections, product lifecycle management, emerging technologies
Additional focus on professional writing, speaking skills, and hands-on tools like e-CTD, eSUGAM, and 356h submissions.
Key Features & Benefits
- Industry-relevant training with experiential learning at Biocon’s Regulatory Science department
- Hands-on sessions at premier sites: PharmaReady (NJ), Glova (Bengaluru), CDSCO (New Delhi), JSS Hospital (Mysuru)
- 100% guaranteed interview opportunities with leading pharma/biopharma companies
- Proven 100% placement record across previous batches
- Merit scholarships reducing financial burden significantly
- Development of soft skills alongside technical expertise
- Access to nutritious meals, transport, and accommodation support during training
Eligibility Criteria
- Educational Qualification: B.Pharm / M.Pharm; M.Sc in Biotechnology / Microbiology / Biochemistry / Chemistry
- Minimum Marks: CGPA 6.8 or above (on a scale of 10) or 65% aggregate
- Experience: 1 year in pharma industry is an added advantage (not mandatory)
- Strict adherence to criteria required for application consideration
How to Apply
Interested candidates meeting the eligibility criteria should apply promptly as admissions are now open for Batch 5.
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Biocon Academy LinkedIn page.
For career guidance in regulatory affairs and pharma opportunities, explore Pharma Recruiter.
Unlock your potential in global regulatory affairs—apply today and transform your career!
Why Choose This Program
In the rapidly evolving biopharma sector, regulatory expertise is crucial for drug approvals and market access worldwide. This program stands out with its industry-academia synergy, practical focus, and exceptional placement support.
Graduates enter roles in regulatory submissions, compliance, clinical affairs, and pharmacovigilance at top organizations. With Biocon’s legacy of innovation and JSS AHER’s academic rigor, participants gain a competitive edge, mentorship from experts, and skills aligned with global standards—making it an ideal launchpad for rewarding regulatory affairs careers in India and abroad.
FAQs
What is the duration and format of the program?
It’s a 16-week full-time intensive program with classroom learning, hands-on training, and industry visits.
Are scholarships available?
Yes, all selected students receive Biocon Merit Scholarships covering 60-75% of the program fee.
What placement support is provided?
100% guaranteed interview opportunities with a track record of 100% placements in leading pharma and biopharma firms.
Is work experience mandatory?
No, but 1 year in the pharma industry is an added advantage for selection.