Biosimilars expert in regulatory affairs

min $50 USD / hour

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min $50 USD / hour

We are looking for an expert in regulatory affairs to help with our three biosimilar biologics projects. Arfe are developing them in the US and in the EU, so need expertise in the EU and U.K. Scope of work includes: 1. helping to obtain a meeting to obtain Scientific Advice from EMA; 2. help interact with US team to devise best Phase II-III protocols for PK/PD and clinical efficacy/safety; and 3. help oversee all European operational aspects of development and commercialization. We plan to have an office in Dublin, Ireland, but expert can be located anywhere in Europe to perform duties. Call if you have questions or comments. Dr. Joseph Sinkule U.S. Phone: (480) 254 5871 (Mountain time zone).

ID Projek: 28242048

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4 pekerja bebas membida secara purata $50 USD/jam untuk pekerjaan ini

@umg536

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$50 USD dalam 786 hari

5.0

(6 ulasan)

3.9

@OpexSolutions

Dear Sir/Madam, I would like to apply for your "Biosimilars expert in regulatory affairs" job. I have an MBA degree with courses in ISO 13485 (Medical Devices), OHSAS 18001 (Occupational Health & Safety), ISO 9001 (Quality Management System), ISO 14001 (Environmental Management), ISO 22301 (Business Continuity) and ISO 27001 (Information Security). We developed Product Information File (PIF) for a Cosmetic. I have a Pharmacy Masters in my team. We have provided Regulatory Affairs support for registration of Covid-19 related medical supplies such as Sanitizers, Masks, Gloves and Gowns to four importers in USA and Canada. For the last two years provided ISO 13485 and regulatory affairs support and registration of medical devices in various countries for American Screening LLC. Also developed Tech Files for them and got the organization MDSAP certification. I have also done FDA EUA Application process for Covid-19 Test Kits. We have provided Consultancy and developed Documentation for the following projects: 1- ISO 22716 Cosmetic GMP at ILNP, USA. 2- ISO 22716 Cosmetic GMP at PurOlea Cosmetics Lab, USA. 3- Cosmetic GMP ISO 22716 at Ozcare Cosmetics, Australia. I am really excited by your project and would like to discuss it at a time of your convenience. Waiting for a positive response from your side. Yours Sincerely, Kamran Vardag

$50 USD dalam 25 hari

5.0

(1 ulasan)

3.0

@rajuyelheri7

Hey there Have done PhD in medical microbiology and having 12 years experience in teaching and research , my major area is drug resistance Ping me to discuss further Regards RY

$50 USD dalam 40 hari

3.0

(2 ulasan)

0.6

@waseemchaudhary4

Hey man I am new on this I have experienced of seven years in writing and I am making blogs for newspaper from 18 years I can do your work at the best possible manner I ll sure you will get the best possible result at low cheapest budget. So please have a chat with me if GOD help me then i ll very happy to work with you

$50 USD dalam 40 hari