Work as Lead Clinical Trials & Regulatory Intelligence at MakroCare
MakroCare Expert Strategic Development and Commercialization Global Partner for Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
Post : Lead Clinical Trials & Regulatory Intelligence
1. Preparing regulatory intelligence summaries for drugs, devices and IVDs.
2. Handling adhoc or additional projects
3. To give trainings for the team members whenever required
4. To give plans for enhancement of product or team building
5. To perform QC of the work done by team members.
6. keeping up to date with changes in regulatory legislation and guidelines
7. Seek opportunities to enable better intelligence product solutions and plan for the implementation of those solutions.
8. Responsible for conducting intelligence research & analysis on public, biotech and pharma companies and universities related to drug research and development.
9. Provide Intelligence production advice and input to vistaar.
10. Develop sound strategies to achieve organizational and regulatory goals.
11. Demonstrate knowledge of compliance standards, exhibit accuracy and thoroughness in work and deliverable.
12. Able to deal with frequent change, delays or unexpected events.
• M.Pharmacy / M.sc. Life sciences.
• Top primary skills required for this role: Sound knowledge on all regulatory requirements, approval process, and product development, including research, clinical trials, and manufacturing practices.
• Secondary skills required for this role: In-depth secondary market research from online web sources, company websites and third party sources. Some times.
• Tertiary skills required for this role: Team Handling.
Experience : 5-7 years
Qualification : M.Pharm, M.Sc
Location : Hyderabad
Industry Type : Clinical
End Date : 16/05/2020
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