Clinical Regulatory Affairs Career Research and Resources
Suraksha Pharma Pvt. Ltd.
Submitting and monitoring the relevant regulatory ACTD Dossiers, COPP's, and all supporting documents for Country specific registration for pharmaceuticals & cosmetics. Assisted paper and NeeS submission to different ASEAN, ROW and PEPFAR markets. Involved in submission of DMF’s, Annual Reports to ASEAN authorities
Avg. Salary: $0 · Company Rank: Not Available
Biocon Research Limited
•Authored and Prepared the CMC section for various Biosimilar projects for FDA and EMA filings (IND, IMPD, NDA.MAA, supplements and amendments) •Prepared Annual reports for assigned projects. •Served as a Regulatory representative in project teams and provided regulatory support (strategy) for new products/therapies and modifications to the existing products. •Evaluated key issues for discussion and negotiated with Health ...
Avg. Salary: $85,000 · Company Rank: Not Available
Biocon Research Limited
Prime focus on Microbial upstream process optimisation with hands-on experience in 1. Handling, culturing and thawing of Microbial cell banks 2. Media and feed preparation/optimization 3. Optimising process parameters for productivity and product quality 4. Handling fermenters at 1 L and 10 L scale 5. Scale-up and Scale- down studies at Upstream stage 6. Technology transfer of the optimised process to the commercial scale ...
Avg. Salary: $85,000 · Company Rank: Not Available
Quest Diagnostics
Liaison Manager between Clinical Trials (Pharma/IVD) Nichols Institute reference laboratories, San Juan Capistrano, Valencia, UK, Singapore, and China. Implement/Respond correct actions or special handling procedures set forth by our sponsors and company authority
Avg. Salary: $95,000 · Company Rank: Not Available
Quest Diagnostics
Supervisor of Processing Personel and assisted in the "won" studies awarded to the Nichols Institute.
Avg. Salary: $95,000 · Company Rank: Not Available
Quest Diagnostics
Assisted with highly technical questions, providing support material for esoteric testing, and conferring w the laboratory staff and genetic councelors to find specific answers to their questions
Avg. Salary: $95,000 · Company Rank: Not Available
Quest Diagnostics
operated, performed, compiled various Coagulation/Immuno-Chemistry assays under the direct supervision of a licensed California Licensed Scientist.
Avg. Salary: $95,000 · Company Rank: Not Available
Quest Diagnostics
Input patient test orders and demographic information into the NIRL/LIS/QLS laboratory ordering systems
Avg. Salary: $95,000 · Company Rank: Not Available
Professional Animal Laboratory
Chemist/high volume reference testing lab worked in all departments/infectious disease/chemistry/thyroid-was back up for Microbiology department. Ran hundreds of patient animal testing each night/via lab analyzers and RIA kits etc.
Avg. Salary: $95,000 · Company Rank: Not Available
Ingredient Identity, LLC
Provided Regulatory advice to clients, Wrote initial assessments of new products, wrote Regulatory submissions for new product registrations, conducted GMP audits of laboratories and manufacturing plants. Assessed proposed product/process changes for regulatory impacts.
Avg. Salary: $135,000 · Company Rank: Not Available
