Biocon JSS AHER Certificate Program in Global Regulatory Affairs

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'.

The program equips the student with the relevant industry skills required to be successful in their career as a Regulatory Affairs professional. Upon completion of the program the student shall be able to know key regulatory and compliance elements with respect to GMP, prepare for the readiness and conduct of audits and inspections, understand the basics of regulatory compilation and submission and approval process and regulatory requirements for drugs, biologics, and devices. The program aims at imparting knowledge about the regulatory requirements for pre-clinical and clinical development of drugs and biologics, and regulatory approval process in regulated markets including ICH region and emerging markets including India.

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, Mysuru 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.

Best-in-Class 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

Course Modules

Introductory/ Preparatory Regulatory Affairs

  • Introduction to Regulatory Affairs
  • Overview of Pharmaceutical markets and regulations
  • GMP and GLP
  • Intellectual Property and Intellectual Property Rights

Small Molecule Regulatory Affairs (Drugs)

  • Regulated Markets like USA, European Union, and Japan
  • ROW Markers like India, ASPAC (China, South Korea, Malaysia, Singapore), LATAM (Mexico, Columbia, Brazil), and Emerging markets like Africa (Tanzania and South Africa) and Middle East (any 2 countries)

Large Molecule Regulatory Affairs (Biologics)

  • USA, European Union, and India

Clinical Regulatory Affairs

  • Clinical Drug Development Process
  • Clinical Research Related Guidelines
  • ICH Guidelines
  • US-FDA Guidance

Medical Devices Regulatory Affairs

  • Basics like introduction, product lifecycle of medical devices, risk-based classification, and essential principles of medical devices and IVDs, and differences between medical devices, IVDs and Combination Products from pharmaceuticals
  • IMDRF/GHTF
  • USA
  • European Union
  • Ethics
  • Quality

Documentation and Regulatory Approvals

  • Documentation in pharmaceutical industry
  • Dossier and submission
  • Audits
  • Inspections
  • Product lifecycle management
  • Emerging Technologies

Eligibility

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.

Student Facilities

At Biocon Academy, the students have to go through a rigorous curriculum so that by the time their course comes to an end, they are industry-ready and sought after by multiple companies. We encourage them to remain focussed and excel in everything they do. For the benefit of the students, we assist them with a couple of facilities to ensure they just focus on the curriculum.

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Campus Placement

At Biocon Academy, we provide 100% interview opportunities to all our students. Ever since inception, Biocon Academy has witnessed 100% placement record in all the courses and batches with students being selected for leading pharma and biopharma companies and startups.


Transport

We understand that commuting to different locations for industry training can get challenging especially when students have to arrange for it themselves. Therefore, students are provided with group transport facilities from Biocon Academy to different training locations and then back to the Academy.

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Meals

Throughout the course, Biocon Academy students are provided with nutritious and sumptuous lunch at the Biocon Academy premises. They also have access to beverage vending machines for tea, coffee, and milk throughout the day.


Accommodation

Students come to study at Biocon Academy from different parts of the country and we often help them by offering suggestions and recommendations regarding their stay. Feel free to reach out for any assistance related to accommodation.

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