REGULATORY AFFAIRS

Department of Pharmaceutical Regulatory Affairs

The Department of Pharmaceutical Regulatory Affairs was established in the year 2026 with the introduction of the M.Pharm (Pharmaceutical Regulatory Affairs) programme. The department is dedicated to imparting comprehensive knowledge on pharmaceutical regulations, drug approval processes, regulatory submissions, Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), pharmacovigilance, quality systems, intellectual property rights, and global regulatory guidelines. The programme equips students with the skills required to ensure compliance with national and international regulatory requirements throughout the lifecycle of pharmaceutical products.

The department provides a conducive learning environment through modern teaching facilities, case-based learning, regulatory document preparation, seminars, workshops, industrial interactions, and research activities. Students are encouraged to undertake projects in emerging areas of regulatory science and gain exposure to current industry practices. The programme prepares graduates for rewarding careers in pharmaceutical industries, regulatory agencies, clinical research organizations, pharmacovigilance, medical writing, quality assurance, and other healthcare sectors both in India and abroad.

Career Opportunities

Graduates of M.Pharm (Pharmaceutical Regulatory Affairs) can pursue careers as:

Regulatory Affairs Executive/Manager.
Regulatory Submission Specialist.
Medical Writer.
Pharmacovigilance Associate.
Quality Assurance Professional.
Clinical Research Associate.
Regulatory Intelligence Specialist.
Drug Safety Associate.
Validation and Compliance Officer.
Positions in CDSCO, State Drug Control Departments, USFDA, EMA, MHRA, and other global regulatory organizations.

Available Facilities

The Department of Pharmaceutical Regulatory Affairs is equipped with modern teaching and learning facilities to provide students with practical exposure to regulatory science and pharmaceutical compliance. The department offers:

Smart classroom with LCD projector and internet-enabled learning.
Dedicated computer systems with high-speed internet access.
Access to national and international regulatory guidelines (CDSCO, USFDA, EMA, ICH, WHO, MHRA, etc.).
Regulatory dossier preparation and documentation training.
Medical writing and scientific documentation facilities.
Pharmacovigilance and drug safety case study training.
Access to e-journals, e-books, and digital library resources.
Departmental seminar hall for guest lectures, workshops, and presentations.
Research guidance for dissertations, publications, and consultancy projects.
Industrial visits, internships, and interactions with regulatory experts from the pharmaceutical industry.

These facilities enable students to gain both theoretical knowledge and practical skills required for careers in Pharmaceutical Regulatory Affairs.