Openings in Pfizer for Regulatory affairs Assistant manager

Openings in Pfizer for Regulatory affairs Assistant manager

 

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About Pfizer : 

One of the major contributor of medicines globally ranking in top 10 pharma companies. The industry equipped with more than 1500 scientists with more than 5 million testing labs globally and over 36 clinical trials before the first perception. In the area of biotechnological medicine  with 25000 clinical researchers testing every day world wide. 
The company has located its head quarters in New York with the rank 57 in fortune 500 companies, founded in 1849, which is 170 years ago. Form have joint ventures with GSK and Mylan for improving the quality of medicines.
Large portfolio including branded and generics with products listed from A to Z. Applies rare diseases research to unveil the new therapy treatment, more than 30 million people in USA and 350 million globally uses the medicines for rare disease treatments. Several hematological and neurological rare disease therapies are in research phase. Gene therapy is one of the promising and rapidly developing portfolio in the companies profile, placing genetically corrected copies to patients cells. Having collaboration with Spark  therapeutics investigating SPK-9001. As a snapshot  35 projects are in Phase 1, 34 are being in phase 2, 23 in phase 3, 9 went for registration with a total of 101 (metrics as of July 2019)  
Constantly providing medicines in the areas of Hospital (anti infectives), oncology, anti inflammatory, oncology, rare diseases, biosimilars, vaccines and new molecular entities.
Partnering in social responsibility by delivering medicines in remote areas and uplifting the needed areas.

About the Job : 


Experience : 7-14 years in Regulatory or quality compliance role

candidate should have masters or bachelors degree from a reputed college/ University

Should have regulatory guidelines knowledge and practices

Should be a good communicator and problem solver

Need to escalate potential issues if unresolved to the SLT

Understanding the flow and should submit the metric to reveal the pattern of filings

Strong hold on CMC-LCM  and need to collaborate with global colleagues.