General Manager - Regulatory Affairs at SYMED LABS LIMITED
Industry
Medical / Health Care / Pharmaceuticals
About
I am a pharma regulatory affairs professional with over 15 years of experience.
Regulatory strategy making, Team management, Updation of guidelines and their implications
Co-ordination with Marketing & Business development.
Implement QA systems and generate SOPs.
Compilation of DMF in CTD Format including supplements and annual reports to be submitted to the USFDA, other Regulatory Agencies and customers - in the US, Canada, Germany, and EU Countries.
Compilation and filing of CEP/ COS; with EDQM.
Answering the queries related to CMC section from the Customers and Regulatory Agencies.
Obtained CEP certificates and USFDA approval for manufacturing site for bulk drugs.
Specialties: Strong...
We鈥檝e updated our privacy policy so that we are compliant with changing global privacy regulations and to provide you with insight into the limited ways in which we use your data.
You can read the details below. By accepting, you agree to the updated privacy policy.
