Regulatory Affairs Courses in Pune
Regulatory Affairs is an industry that oversees how foods, drugs, and medical products are developed, tested, manufactured, marketed, and distributed to certify that they meet regulatory standards for human use. Regulatory Affairs department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. The manufacturers’ compliance with applicable global legislative and regulatory requirements at each stage of product development is one such activity solely dependent on Regulatory Affairs professionals. In the drug, medical device, and biologic product industries, these phases include: research and development, clinical trials, regulatory submissions, manufacturing, marketing, distribution, reimbursement, and post-market surveillance. Regulatory professionals remained engaged with various products, facilities, manufacturing operations, and distributors along the farm-to-fork lifecycle in the food and related industries.
The in depth development and distribution of medical technological advancements and drugs, disease-free food, improving people’s health and welfare around the world is all looked after by these professionals.
RA work profile
The bridge between the pharma companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation are maintained by these RA professionals and specialists. The safety and efficiency of drugs and medical devices in the health care industry is solely on the RA professionals. They are solely responsible for gathering, evaluating, organizing, managing and collating information in a variety of formats/ ensuring compliance with regulations set by global regulatory authorities.
How much do these RA professionals earn?
RA at the base or starting level can expect to earn an average total compensation (includes tips, bonus, and overtime pay) of ₹307K. An early career Regulatory Affairs Specialist with 1-4 years of experience earns an average total compensation of ₹386K. A with 5-9 years of experience mid-career Regulatory Affairs Specialist earns a total compensation of ₹615K. Proficient with10-19 years of experience earns an average total compensation of ₹808K.
For regulatory affairs careers in clinical research and in the pharmaceutical industry at large one can undergo Advanced and Diploma courses in Regulatory Affairs and Clinical Research courses in Pune. DCS offers one year and six months Advanced and Post Graduate Diploma in Clinical Research and Regulatory Affairs. DCS is the centre for skill and entrepreneurship development in clinical research industry offering excellent platform and knowledge to land into a good company or enterprise and can boost their growth opportunities by availing the benefits of our wide network and contacts across the companies and industries. Anyone prefers to be in Clinical research industry and medical profession can undergo for this programme for detailed knowledge on the same. This is practically driven and centered training programme on the tasks expected of a RA professional in the clinical research industry. In this RA training we provide you with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the life cycle.
Individuals are going to get the best of:
- Better industrial training and skills,
- Better knowledge of the industry,
- In depth training of the industry regulations and work processes
- Internationally certified with all market standards and integrity
- Domain expertise and getting hands on practical exposure
Course Objectives and Gals
- This course is based on the ICH guideline and and is a complete training solution to acquire and expertise in the industry.
- Understand the Global regulations in various countries including ICH regulations.
- Soft Skills development including presentation, writing, communication skills, and Interview Skills etc
- Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety and drug regulatory bodies as per industry standards.
Eligibility Criteria
- Doctors (MBBS/ MD/ BDS/ BAMS/ BHMS)
Pharma Candidates (B. Pharm / M. Pharm)
Life Sciences (M.Sc. / B.Sc)
- Credits/sessions: 48
- hours per session/credit: 3/5 in weekdays or weekends respectively
- credits/sessions: 96
- hours per session/credit: 3/5 in weekdays or weekends respectively
After 3-4 months of the course as per students’ performance and scorecard.
In Placement Preparation Program, DCS trains all students for facing interview and selection process or procedures of the corporate world like Writing Skills Communication Skills.