Marg Career Library - Regulatory Affairs Specialists

Overview:

Arrange and report inside administrative cycles, like inner reviews, assessments, permit reestablishments, or enrollments. May order and plan materials for accommodation to administrative offices.

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Career Path:

A Bachelor’s degree in the field of science especially pharmacy, biology, pharmacology, microbiology, biochemistry is a must for getting into as RA.

For junior positions, undergraduates or postgraduates is sufficient but for senior positions In the field of clinical research, it is mandatory for a person to have a doctorate degree.

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Top Colleges:

JSS College of Pharmacy, Mysore
JSS College of Pharmacy, Ooty
Sri Ramachandra Institute of Higher Education and Research, Chennai
SRM College of Pharmacy, Kattankulathur
MCOPS Manipal - Manipal College of Pharmaceutical Sciences
Nirma University, Ahmedabad

Job Opportunities:

Work in pharmaceuticals industry
Work in medical device industry
Biotechnology companies
Clinical research

Job Responsibilities:

Arrange review or market withdrawal exercises as fundamental.
Survey clinical conventions to guarantee assortment of information required for administrative entries.
Give pre-, continuous, and post-investigation follow-up help to administrative auditors.
Survey unfriendly medication responses and document all connected reports as per administrative office rules.
Suggest mediation of item grievances.
Create or lead representative administrative preparing.
Speak with administrative offices in regards to pre-accommodation methodologies, likely administrative pathways, consistence test necessities, or explanation and follow-up of entries under survey.
Prescribe changes to organization methods in light of changes in guidelines or norms.
Take part in inside or outer reviews.
Incorporate and keep up with administrative documentation data sets or frameworks.
Survey item limited time materials, naming, group records, determination sheets, or test techniques for consistence with pertinent guidelines and arrangements.