In a pharmaceutical industry Regulatory affairs (RA) professionals play significant role because it is concern about the healthcare product lifecycle, it provide strategic, tactical and operational direction and support for working within regulations to expedite the development and delivery of safe and effective healthcare products to individuals around the world.
Current scenario: In year 2015 the Cabinet Committee on Economic Affairs (CCEA),India has approved Rs.1750 crore for strengthening the drug regulatory system both at the Central and the State. This amount utilize to increase manpower in existing drug testing laboratories.
Salary: Fresher can start from 3.5 lakh per annum.
Eligibility: Pharmacy Post graduates.
Scope of regulatory affairs professional
Regulatory affairs professionals are employed in private & public sector industry, government regulatory authorities and academics.
In following area regulatory professionals can work:
- Medical devices
- In vitro diagnostics
- Biologics and biotechnology
- Nutritional Products
- Clinical trial
- Product Management
Segment/Parameter of Regulatory Affairs
- Design =Development Plan
- Co-ordination= Writing/reviewing, supervising
- Construction= Assembling & Submission Management
- Testing= Where are the weaknesses
- Drug regulations
- National Laws (e.g. India-CDSCO, UK – Medicines Act, US- CFR)
- Regional Laws (EC directives)
- National and Regional Guidelines
- International Guidelines (ICH)
Reason to choose DRA as a career option
- Good Salary
- Lack of availability of skilled professional
- International exposure
- More chances to get job at abroad after 3-5 year of experience
- White collar job
DRA Institute in India
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