MakroCare is an 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.

Educational Qualification with Specialization: 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.

Main Responsibilities:

• 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.