Biocon JSS AHER Certificate Program in Global Regulatory Affairs – Admissions Open!
Biocon Academy partners with JSS Academy of Higher Education and Research (formerly JSS University), a leading institute of higher education and a deemed-to-be university recognized by MHRD and accredited by NAAC with A+, to deliver a first of its kind ‘Certificate Program in Global Regulatory Affairs’.
Program Highlights
This 16-week program is designed to impart fundamental knowledge on various good regulatory practices, clinical development process, documentation and submission, regulations for drugs, biologics and medical devices and legislation in regulated and emerging markets, through an intensive curriculum delivered by the renowned faculty from JSS AHER, Mysore and Subject Matter Experts from Biocon Group.
Career Opportunities
A regulatory affairs (RA) professional is expected to have a broad understanding of various aspects including drug discovery & clinical research, patent and legal strategies, etc. besides having sound knowledge of global and country specific regulatory requirements. With this new course, students are offered complete practical exposure in various disciplines, much before they are recruited by any pharma and biopharma company.
Customised Curriculum
During the program, students will undergo experiential learning with Biocon Regulatory Science department, case studies will be conducted by Subject Matter
Experts, and hands-on training in making e-CTD, eSUGAM filings and 356h submission. Students will also get an opportunity to visit JSS Hospital to understand clinical trial proceedings. Lastly, they will be provided training in professional writing and speaking skills to augment their success in regulatory space.Key Differentiators
- One-of-its-kind 16-week program for pharmacy students in India
- Experienced faculty from Biocon and JSS AHER
- Hands-on training including PharmaReady- NJ, Glova- Blr, CDSCO-New Delhi, JSS Hospital-Mysuru, Employee Shadowing, Pharmacovigilance Report 356h, and e-SUGAM
- Expert guidance and mentorship
- Job-ready skills with 100% guaranteed interview opportunities
Course Modules
- Introductory/ Preparatory Regulatory Affairs
- Small Molecule Regulatory Affairs (Drugs)
- Large Molecule Regulatory Affairs (Biologics)
- Clinical Regulatory Affairs
- Medical Devices Regulatory Affairs
- Documentation and Regulatory Approvals
Eligibility Criteria
Education Qualification:
- B Pharm / M Pharm
- M Sc Biotechnology / Microbiology / Biochemistry / Allied Science
Minimum CGPA/Percentage Required:
- CGPA: 6.8 or above on a scale on 10
- Percentage: 65%
- 1 year of work experience in pharma industry would be an added advantage.
- Adherence to the eligibility criteria is mandatory. Kindly note the same and apply only if you fit the desired eligibility criteria as mentioned above.
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