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Online Resumes with "Dossier submissions"
Clinical Research Associate - 5 yearsexperience - Regulator Affairs
I am currently looking for an appropriate job opening in a Research Institute. I have five years experience as a Clinical Research Associate (as Regulatory Officer and Medical Writer). I had been working with reputed pharmaceutical companies in India. I have led a team of Medical writers and as a part of them, I have written Clinical and Pre-clinical overviews on more than 100 molecules for regulatory dossier submission ...
Tags for this Online Resume: Protocol Development, Clinical study report, Clinical study audit and monitoring, Regulatory dossier submission, RMP, PSUR, Leaflet, Regulatory queries
Regulatory affairs assistant
To work on the assignments in Drug Regulatory Affairs with an organisation of repute preferably in Pharmaceuticals Domain.
Tags for this Online Resume: drug, regulatory affairs, clinical research, GCP, Dossier submission, Pharma industry
Pharmaceutical Analyst
To contribute in Pharmaceutical industry at any level for product development, validation, quality commercial manufacturing and regulatory dossier submissions.
Tags for this Online Resume: GLP/GMP, Pharmaceutical analysis, ICH Quality, method development, validation, regulatory FDA documentation
Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality
Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...
Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.
Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA
