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jeevan reddy

jeevan reddy

Dubai, دبي
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About jeevan reddy:

As a person, I am friendly and extrovert and believe that I can always learn from other people. I enjoy working independently as well as working with Team. I am recognized by my peers as someone who is a team player and approachable, and from my team members, as an effective mentor and able to give needed confidence during high pressure. Further, I enjoy taking ownership and responsibility and I am dedicated in delivering what I promised.


Regulatory affairs 

Experience

  • Registration of Manufacturing company and its products, Renewals, Minor variations, mainly from Australia, Turkey, Brazil, USA
  • Involved in preparation of dossiers of different formulations such as Tablets, and Oral Liquids & Sterile Powder for Injection.
  • Registration and Renewal of the dossiers related to Companies and products such as of GSL (General Sale Product), Veterinary products, Herbal products.
  • Registration of products in UAE Ministry of Health, Dubai Municipality and Ministry of Climate change and Environment depending upon product range.
  • Developing, Translating, reviewing (where required) "Artworks" and leaflet according to the Health Authority Standards.
  • Ensuring that the company’s registration files comply with the requirements of UAE regulatory authorities.
  • Developing and preparing files for submissions for product registration and renewals to strict deadline together with reviewing PILs, and Artworks. 
  • Prepare, process and track regulatory documents
  • Managing regulatory activities on both short & long term company objectives, with external contractors and regional business partners to ensure appropriate standards and time lines are met.
  • Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
  • Keeping up-to-date with changes in regulatory legislation and guidelines along with developing and maintain standard operating procedures or local working practices.
  • Develop regulatory strategies and implementation plans for the preparation and submission of new products.
  • Handle tasks related to releasing consignments for sale from MOCCAE. For example; lab reagents requirements and ordering reference standards from USP, EDQM and from suppliers and registered finished products to sale in specific country.
  • Involved in preparing documents for both Import and Export of the finished products shipment along with the shipment clearance from customs and concerned airport authorities.
  • Arranging all the required HPLC columns, reference standards, Impurities, placebo etc., to the Central Quality Control Lab. 
  • On line Applications and continuous follow-up with health authority (like MOH, Dubai municipality, MOCCAE) for import permits of pharmaceutical products in UAE.
  • Well versed in preparing files for submissions for minor variations of registered products and changes to manufacturing company and site.
  • Excellent customer service skills that make me best in Business Support operations
  • Excellent Coordination skills with multiple Stakeholders
  • Excellent communication skills in English and IT.
  • Having immediate availability to start immediately and flexible with working hours

Education

Msc. Pharmaceutical science, united kingdom.

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